22nd World Congress of Dermatology

SEOUL, KOREA – Twice-weekly clobetasol shampoo alternating with twice-weekly ketoconazole shampoo is a highly effective and well-tolerated treatment for moderate to severe seborrheic dermatitis, a multicenter randomized clinical trial indicates.

The superior efficacy of the combined regimen as compared to monotherapy with either agent alone was sustained with once-weekly ketoconazole shampoo maintenance therapy, Dr. Jean-Paul Ortonne reported at the World Congress of Dermatology.

The 22-center, 12-week study was conducted in Europe, North America, and Asia, and included 326 patients with moderate to severe scalp seborrheic dermatitis. At baseline, 61% of participants had involvement of at least 50% of their scalp.

Subjects were randomized to one of four treatment regimens: alternate weeks of clobetasol propionate shampoo 0.05% twice weekly and ketoconazole shampoo 2% twice weekly for 4 weeks; 4 weeks of either agent alone twice weekly; or clobetasol shampoo four times per week alternating with ketoconazole shampoo twice weekly for 4 weeks. The 4-week treatment phase was followed by 4 weeks of once-weekly ketoconazole shampoo maintenance therapy, then 4 additional weeks of untreated follow-up.

All three clobetasol-containing regimens were significantly more effective than twice-weekly ketoconazole monotherapy in reducing total severity scores at weeks 2 and 4. Indeed, 80%-90% of patients on the three clobetasol-containing regimens had no or only mild erythema, scaling, and itching at week 4, and median severity scores in the three clobetasol-containing regimens had dropped by roughly 70% compared with baseline, according to Dr. Ortonne, professor and chairman of the department of dermatology at the University of Nice–Sophia Antipolis (France).

By week 8, after 4 weeks of ketoconazole shampoo maintenance therapy, the groups earlier on clobetasol monotherapy or clobetasol four times weekly alternating with ketoconazole twice weekly both demonstrated slight worsening in terms of total severity scores, as well as measures of erythema, scaling, and itch. In contrast, efficacy was sustained throughout the maintenance phase in patients earlier assigned to clobetasol twice weekly alternating with ketoconazole twice weekly.

At week 12, after 4 weeks without treatment, efficacy remained highest in the twice-weekly alternating clobetasol/ketoconazole group, the majority of whom had involvement of less than 30% of their scalp area and no or only mild erythema, scaling, and pruritus.

The 4.9% treatment-related adverse event rate was similar in all four treatment arms and consisted mostly of mild burning. No worsening of skin atrophy was observed with any of the regimens. Two patients in the twice-weekly alternating clobetasol/ketoconazole group reported developing mild telangiectasias during the study.

Dr. Ortonne is a consultant to Galderma, the study sponsor.

SEOUL, KOREA – Twice-weekly clobetasol shampoo alternating with twice-weekly ketoconazole shampoo is a highly effective and well-tolerated treatment for moderate to severe seborrheic dermatitis, a multicenter randomized clinical trial indicates.

The superior efficacy of the combined regimen as compared to monotherapy with either agent alone was sustained with once-weekly ketoconazole shampoo maintenance therapy, Dr. Jean-Paul Ortonne reported at the World Congress of Dermatology.

The 22-center, 12-week study was conducted in Europe, North America, and Asia, and included 326 patients with moderate to severe scalp seborrheic dermatitis. At baseline, 61% of participants had involvement of at least 50% of their scalp.

Subjects were randomized to one of four treatment regimens: alternate weeks of clobetasol propionate shampoo 0.05% twice weekly and ketoconazole shampoo 2% twice weekly for 4 weeks; 4 weeks of either agent alone twice weekly; or clobetasol shampoo four times per week alternating with ketoconazole shampoo twice weekly for 4 weeks. The 4-week treatment phase was followed by 4 weeks of once-weekly ketoconazole shampoo maintenance therapy, then 4 additional weeks of untreated follow-up.

All three clobetasol-containing regimens were significantly more effective than twice-weekly ketoconazole monotherapy in reducing total severity scores at weeks 2 and 4. Indeed, 80%-90% of patients on the three clobetasol-containing regimens had no or only mild erythema, scaling, and itching at week 4, and median severity scores in the three clobetasol-containing regimens had dropped by roughly 70% compared with baseline, according to Dr. Ortonne, professor and chairman of the department of dermatology at the University of Nice–Sophia Antipolis (France).

By week 8, after 4 weeks of ketoconazole shampoo maintenance therapy, the groups earlier on clobetasol monotherapy or clobetasol four times weekly alternating with ketoconazole twice weekly both demonstrated slight worsening in terms of total severity scores, as well as measures of erythema, scaling, and itch. In contrast, efficacy was sustained throughout the maintenance phase in patients earlier assigned to clobetasol twice weekly alternating with ketoconazole twice weekly.

At week 12, after 4 weeks without treatment, efficacy remained highest in the twice-weekly alternating clobetasol/ketoconazole group, the majority of whom had involvement of less than 30% of their scalp area and no or only mild erythema, scaling, and pruritus.

The 4.9% treatment-related adverse event rate was similar in all four treatment arms and consisted mostly of mild burning. No worsening of skin atrophy was observed with any of the regimens. Two patients in the twice-weekly alternating clobetasol/ketoconazole group reported developing mild telangiectasias during the study.

Dr. Ortonne is a consultant to Galderma, the study sponsor.

SEOUL, KOREA – Twice-weekly clobetasol shampoo alternating with twice-weekly ketoconazole shampoo is a highly effective and well-tolerated treatment for moderate to severe seborrheic dermatitis, a multicenter randomized clinical trial indicates.

The superior efficacy of the combined regimen as compared to monotherapy with either agent alone was sustained with once-weekly ketoconazole shampoo maintenance therapy, Dr. Jean-Paul Ortonne reported at the World Congress of Dermatology.

The 22-center, 12-week study was conducted in Europe, North America, and Asia, and included 326 patients with moderate to severe scalp seborrheic dermatitis. At baseline, 61% of participants had involvement of at least 50% of their scalp.

Subjects were randomized to one of four treatment regimens: alternate weeks of clobetasol propionate shampoo 0.05% twice weekly and ketoconazole shampoo 2% twice weekly for 4 weeks; 4 weeks of either agent alone twice weekly; or clobetasol shampoo four times per week alternating with ketoconazole shampoo twice weekly for 4 weeks. The 4-week treatment phase was followed by 4 weeks of once-weekly ketoconazole shampoo maintenance therapy, then 4 additional weeks of untreated follow-up.

All three clobetasol-containing regimens were significantly more effective than twice-weekly ketoconazole monotherapy in reducing total severity scores at weeks 2 and 4. Indeed, 80%-90% of patients on the three clobetasol-containing regimens had no or only mild erythema, scaling, and itching at week 4, and median severity scores in the three clobetasol-containing regimens had dropped by roughly 70% compared with baseline, according to Dr. Ortonne, professor and chairman of the department of dermatology at the University of Nice–Sophia Antipolis (France).

By week 8, after 4 weeks of ketoconazole shampoo maintenance therapy, the groups earlier on clobetasol monotherapy or clobetasol four times weekly alternating with ketoconazole twice weekly both demonstrated slight worsening in terms of total severity scores, as well as measures of erythema, scaling, and itch. In contrast, efficacy was sustained throughout the maintenance phase in patients earlier assigned to clobetasol twice weekly alternating with ketoconazole twice weekly.

At week 12, after 4 weeks without treatment, efficacy remained highest in the twice-weekly alternating clobetasol/ketoconazole group, the majority of whom had involvement of less than 30% of their scalp area and no or only mild erythema, scaling, and pruritus.

The 4.9% treatment-related adverse event rate was similar in all four treatment arms and consisted mostly of mild burning. No worsening of skin atrophy was observed with any of the regimens. Two patients in the twice-weekly alternating clobetasol/ketoconazole group reported developing mild telangiectasias during the study.

Dr. Ortonne is a consultant to Galderma, the study sponsor.

SEOUL, SOUTH KOREA — The hyaluronic acid filler Voluma demonstrated excellent efficacy, durability, and patient satisfaction in correcting midface volume deficits at the interim 78-week analysis in a large prospective multicenter study.

At 78 weeks, 84% of patients maintained a clinically meaningful improvement after a single baseline injection and a touch-up injection, if needed, at week 4, Dr. Greg J. Goodman said at the World Congress of Dermatology.

Moreover, 95% of participants pronounced themselves satisfied or very satisfied with the product at the 78-week mark. An equal percentage indicated they would recommend the treatment to others, added Dr. Goodman of Monash University, Melbourne.

Based upon these interim results of what will be a 104-week study – the first-ever formal study of the filler’s long-term effects in daily clinical practice – correction of mild to severe midface volume deficits with Voluma is a safe, effective, long-lasting, and cost-effective alternative to surgical correction, he continued.

The study involved 103 middle-aged subjects with a baseline score of 2-5 on the 6-point Mid-Face Volume-Deficit Scale (MVDS). They were corrected to a 0 or 1, meaning no or mild deficit, by means of a baseline injection of up to 2 cc of Voluma per side. This was followed by an additional injection of up to 2 cc per side if needed at week 4. Patients received a mean total volume of 3.1 mL per side. No further retreatment was permitted until week 78.

A greater than 1-point improvement over baseline MVDS was present in 96% of patients at week 8, 90% at week 52, and 84% at week 78. Similarly, 100% of patients had a greater than 1-point improvement on the 5-point Global Aesthetic Improvement Scale (GAIS)at week 8, 92% at week 52, and 82% at week 78. In all, 78% of patients rated themselves as having more than a 1-point improvement on the GAIS at week 78.

At week 78, 32% of patients received a supplemental injection of Voluma, based upon protocol-defined criteria indicating they had returned to within less than 1 MVDS point of their pretreatment midface volume.

The chief side effect of treatment was mild to moderate bruising at the injection site. This was much more common early in the study, when Voluma was new to Australian physicians.

"We were finding our way back then," Dr. Goodman recalled.

The study was sponsored by Allergan. Dr. Goodman is a consultant to the company.

SEOUL, SOUTH KOREA — The hyaluronic acid filler Voluma demonstrated excellent efficacy, durability, and patient satisfaction in correcting midface volume deficits at the interim 78-week analysis in a large prospective multicenter study.

At 78 weeks, 84% of patients maintained a clinically meaningful improvement after a single baseline injection and a touch-up injection, if needed, at week 4, Dr. Greg J. Goodman said at the World Congress of Dermatology.

Moreover, 95% of participants pronounced themselves satisfied or very satisfied with the product at the 78-week mark. An equal percentage indicated they would recommend the treatment to others, added Dr. Goodman of Monash University, Melbourne.

Based upon these interim results of what will be a 104-week study – the first-ever formal study of the filler’s long-term effects in daily clinical practice – correction of mild to severe midface volume deficits with Voluma is a safe, effective, long-lasting, and cost-effective alternative to surgical correction, he continued.

The study involved 103 middle-aged subjects with a baseline score of 2-5 on the 6-point Mid-Face Volume-Deficit Scale (MVDS). They were corrected to a 0 or 1, meaning no or mild deficit, by means of a baseline injection of up to 2 cc of Voluma per side. This was followed by an additional injection of up to 2 cc per side if needed at week 4. Patients received a mean total volume of 3.1 mL per side. No further retreatment was permitted until week 78.

A greater than 1-point improvement over baseline MVDS was present in 96% of patients at week 8, 90% at week 52, and 84% at week 78. Similarly, 100% of patients had a greater than 1-point improvement on the 5-point Global Aesthetic Improvement Scale (GAIS)at week 8, 92% at week 52, and 82% at week 78. In all, 78% of patients rated themselves as having more than a 1-point improvement on the GAIS at week 78.

At week 78, 32% of patients received a supplemental injection of Voluma, based upon protocol-defined criteria indicating they had returned to within less than 1 MVDS point of their pretreatment midface volume.

The chief side effect of treatment was mild to moderate bruising at the injection site. This was much more common early in the study, when Voluma was new to Australian physicians.

"We were finding our way back then," Dr. Goodman recalled.

The study was sponsored by Allergan. Dr. Goodman is a consultant to the company.

SEOUL, SOUTH KOREA — The hyaluronic acid filler Voluma demonstrated excellent efficacy, durability, and patient satisfaction in correcting midface volume deficits at the interim 78-week analysis in a large prospective multicenter study.

At 78 weeks, 84% of patients maintained a clinically meaningful improvement after a single baseline injection and a touch-up injection, if needed, at week 4, Dr. Greg J. Goodman said at the World Congress of Dermatology.

Moreover, 95% of participants pronounced themselves satisfied or very satisfied with the product at the 78-week mark. An equal percentage indicated they would recommend the treatment to others, added Dr. Goodman of Monash University, Melbourne.

Based upon these interim results of what will be a 104-week study – the first-ever formal study of the filler’s long-term effects in daily clinical practice – correction of mild to severe midface volume deficits with Voluma is a safe, effective, long-lasting, and cost-effective alternative to surgical correction, he continued.

The study involved 103 middle-aged subjects with a baseline score of 2-5 on the 6-point Mid-Face Volume-Deficit Scale (MVDS). They were corrected to a 0 or 1, meaning no or mild deficit, by means of a baseline injection of up to 2 cc of Voluma per side. This was followed by an additional injection of up to 2 cc per side if needed at week 4. Patients received a mean total volume of 3.1 mL per side. No further retreatment was permitted until week 78.

A greater than 1-point improvement over baseline MVDS was present in 96% of patients at week 8, 90% at week 52, and 84% at week 78. Similarly, 100% of patients had a greater than 1-point improvement on the 5-point Global Aesthetic Improvement Scale (GAIS)at week 8, 92% at week 52, and 82% at week 78. In all, 78% of patients rated themselves as having more than a 1-point improvement on the GAIS at week 78.

At week 78, 32% of patients received a supplemental injection of Voluma, based upon protocol-defined criteria indicating they had returned to within less than 1 MVDS point of their pretreatment midface volume.

The chief side effect of treatment was mild to moderate bruising at the injection site. This was much more common early in the study, when Voluma was new to Australian physicians.

"We were finding our way back then," Dr. Goodman recalled.

The study was sponsored by Allergan. Dr. Goodman is a consultant to the company.

SEOUL, SOUTH KOREA – Nearly two-thirds of patients treated with etanercept for scalp psoriasis had a 90% improvement in Psoriasis Scalp Severity Index score at week 12, compared with just 7% of controls, in a phase IV, double-blind, placebo-controlled randomized trial.

Topical scalp psoriasis treatments are often messy and inconvenient, and earn low marks for patient satisfaction and compliance. That is why Dr. Stephen K. Tyring said he and his coinvestigators conducted the phase IV trial of the tumor necrosis factor inhibitor etanercept (Enbrel) for moderate-to-severe scalp psoriasis.

The 124 participants had a baseline mean 64% scalp surface area involvement with a Psoriasis Scalp Severity Index (PSSI) score of 34.5, a 22.3% body surface area involvement, and a Psoriasis Area and Severity Index of 17.5.

Half of the subjects were randomized to etanercept at 50 mg twice weekly for 12 weeks, followed by once-weekly etanercept at 50 mg plus a subcutaneous placebo injection for another 12 weeks. The controls got 12 weeks of twice-weekly placebo injections, followed by 12 weeks of twice-weekly etanercept at 50 mg per dose.

The prespecified primary study end point was the mean percentage improvement in PSSI from baseline through week 12, which was 87% in the etanercept arm and 20% among controls. At week 12, 63% of the etanercept group had a PSSI 90 response – that is, at least a 90% improvement in PSSI – compared with just 7% of controls. A significant difference between the two study arms was evident as early as week 4, Dr. Tyring reported at the World Congress of Dermatology.

A week 12 PSSI 75 response was noted in 86% of the etanercept group, compared with 11% of controls. The etanercept group had a mean 74% reduction in PASI score at week 12, versus an 11% improvement among controls.

The improvement in scalp itch seen with etanercept was particularly impressive, he said. At baseline, less than 2% of patients had a Scalp Pruritus Score of 0, but by week 12 this was the case for 42% of the etanercept group and 8% of controls, noted Dr. Tyring, a dermatologist at the University of Texas in Houston.

The improvements in scalp and skin psoriasis seen with 12 weeks of twice-weekly etanercept were maintained through week 24, despite the switch to a lower dose. Moreover, patients initially assigned to 12 weeks of placebo showed improvements at week 24 – after 12 weeks on etanercept – similar to those seen at 12 weeks among patients assigned to the tumor necrosis factor inhibitor from the start.

For example, at week 24 a PASI 90 was achieved in 68% of the all-etanercept group and 67% in patients on 12 weeks of placebo followed by etanercept. At week 24, PASI 75 response was noted in 69% of the all-etanercept group and 59% of those on etanercept after placebo. And at week 24, a Scalp Pruritus Score of 0 was documented in 47% of patients on etanercept throughout the study and 49% of those on the biologic alone for the last 12 weeks.

The most common adverse events among study participants were upper respiratory infections in 12%, nasopharyngitis in 8%, and injection site reactions in 6%.

The clinical trial was sponsored by Amgen. Dr. Tyring has received research funding from, and has been a speaker for, the company.

SEOUL, SOUTH KOREA – Nearly two-thirds of patients treated with etanercept for scalp psoriasis had a 90% improvement in Psoriasis Scalp Severity Index score at week 12, compared with just 7% of controls, in a phase IV, double-blind, placebo-controlled randomized trial.

Topical scalp psoriasis treatments are often messy and inconvenient, and earn low marks for patient satisfaction and compliance. That is why Dr. Stephen K. Tyring said he and his coinvestigators conducted the phase IV trial of the tumor necrosis factor inhibitor etanercept (Enbrel) for moderate-to-severe scalp psoriasis.

The 124 participants had a baseline mean 64% scalp surface area involvement with a Psoriasis Scalp Severity Index (PSSI) score of 34.5, a 22.3% body surface area involvement, and a Psoriasis Area and Severity Index of 17.5.

Half of the subjects were randomized to etanercept at 50 mg twice weekly for 12 weeks, followed by once-weekly etanercept at 50 mg plus a subcutaneous placebo injection for another 12 weeks. The controls got 12 weeks of twice-weekly placebo injections, followed by 12 weeks of twice-weekly etanercept at 50 mg per dose.

The prespecified primary study end point was the mean percentage improvement in PSSI from baseline through week 12, which was 87% in the etanercept arm and 20% among controls. At week 12, 63% of the etanercept group had a PSSI 90 response – that is, at least a 90% improvement in PSSI – compared with just 7% of controls. A significant difference between the two study arms was evident as early as week 4, Dr. Tyring reported at the World Congress of Dermatology.

A week 12 PSSI 75 response was noted in 86% of the etanercept group, compared with 11% of controls. The etanercept group had a mean 74% reduction in PASI score at week 12, versus an 11% improvement among controls.

The improvement in scalp itch seen with etanercept was particularly impressive, he said. At baseline, less than 2% of patients had a Scalp Pruritus Score of 0, but by week 12 this was the case for 42% of the etanercept group and 8% of controls, noted Dr. Tyring, a dermatologist at the University of Texas in Houston.

The improvements in scalp and skin psoriasis seen with 12 weeks of twice-weekly etanercept were maintained through week 24, despite the switch to a lower dose. Moreover, patients initially assigned to 12 weeks of placebo showed improvements at week 24 – after 12 weeks on etanercept – similar to those seen at 12 weeks among patients assigned to the tumor necrosis factor inhibitor from the start.

For example, at week 24 a PASI 90 was achieved in 68% of the all-etanercept group and 67% in patients on 12 weeks of placebo followed by etanercept. At week 24, PASI 75 response was noted in 69% of the all-etanercept group and 59% of those on etanercept after placebo. And at week 24, a Scalp Pruritus Score of 0 was documented in 47% of patients on etanercept throughout the study and 49% of those on the biologic alone for the last 12 weeks.

The most common adverse events among study participants were upper respiratory infections in 12%, nasopharyngitis in 8%, and injection site reactions in 6%.

The clinical trial was sponsored by Amgen. Dr. Tyring has received research funding from, and has been a speaker for, the company.

SEOUL, SOUTH KOREA – Nearly two-thirds of patients treated with etanercept for scalp psoriasis had a 90% improvement in Psoriasis Scalp Severity Index score at week 12, compared with just 7% of controls, in a phase IV, double-blind, placebo-controlled randomized trial.

Topical scalp psoriasis treatments are often messy and inconvenient, and earn low marks for patient satisfaction and compliance. That is why Dr. Stephen K. Tyring said he and his coinvestigators conducted the phase IV trial of the tumor necrosis factor inhibitor etanercept (Enbrel) for moderate-to-severe scalp psoriasis.

The 124 participants had a baseline mean 64% scalp surface area involvement with a Psoriasis Scalp Severity Index (PSSI) score of 34.5, a 22.3% body surface area involvement, and a Psoriasis Area and Severity Index of 17.5.

Half of the subjects were randomized to etanercept at 50 mg twice weekly for 12 weeks, followed by once-weekly etanercept at 50 mg plus a subcutaneous placebo injection for another 12 weeks. The controls got 12 weeks of twice-weekly placebo injections, followed by 12 weeks of twice-weekly etanercept at 50 mg per dose.

The prespecified primary study end point was the mean percentage improvement in PSSI from baseline through week 12, which was 87% in the etanercept arm and 20% among controls. At week 12, 63% of the etanercept group had a PSSI 90 response – that is, at least a 90% improvement in PSSI – compared with just 7% of controls. A significant difference between the two study arms was evident as early as week 4, Dr. Tyring reported at the World Congress of Dermatology.

A week 12 PSSI 75 response was noted in 86% of the etanercept group, compared with 11% of controls. The etanercept group had a mean 74% reduction in PASI score at week 12, versus an 11% improvement among controls.

The improvement in scalp itch seen with etanercept was particularly impressive, he said. At baseline, less than 2% of patients had a Scalp Pruritus Score of 0, but by week 12 this was the case for 42% of the etanercept group and 8% of controls, noted Dr. Tyring, a dermatologist at the University of Texas in Houston.

The improvements in scalp and skin psoriasis seen with 12 weeks of twice-weekly etanercept were maintained through week 24, despite the switch to a lower dose. Moreover, patients initially assigned to 12 weeks of placebo showed improvements at week 24 – after 12 weeks on etanercept – similar to those seen at 12 weeks among patients assigned to the tumor necrosis factor inhibitor from the start.

For example, at week 24 a PASI 90 was achieved in 68% of the all-etanercept group and 67% in patients on 12 weeks of placebo followed by etanercept. At week 24, PASI 75 response was noted in 69% of the all-etanercept group and 59% of those on etanercept after placebo. And at week 24, a Scalp Pruritus Score of 0 was documented in 47% of patients on etanercept throughout the study and 49% of those on the biologic alone for the last 12 weeks.

The most common adverse events among study participants were upper respiratory infections in 12%, nasopharyngitis in 8%, and injection site reactions in 6%.

The clinical trial was sponsored by Amgen. Dr. Tyring has received research funding from, and has been a speaker for, the company.

SEOUL, SOUTH KOREA – Acute cutaneous graft-versus-host disease in stem cell transplant recipients may be a manifestation of herpes simplex virus–associated erythema multiforme.

This novel hypothesis is supported by a chain of scientific evidence backed by a plausible mechanism of action, said Laure Aurelian, Ph.D., at the World Congress of Dermatology. And, if the hypothesis is correct, the implications for clinical practice will be significant.

"Viral etiology, we believe, should be seriously considered in the management of patients with graft-versus-host disease [GVHD] in the skin, because the way they are treated now – with acyclovir after stem cell transplantation has occurred – is definitely not helpful. If we are correct, then initiating the antiviral therapy earlier, and probably by IV, is the right way to go," said Dr. Aurelian of the University of Maryland, Baltimore.

After stem cell transplantation, the standard practice of initiating oral acyclovir at 800 mg twice daily starting on day 3 post procedure to preemptively quell the immunosuppression-triggered reactivation of latent herpes simplex virus (HSV) infection is too late, she said. "This standard of care is obviously not helping," given how often acute GVHD occurs.

In earlier work, Dr. Aurelian and her colleagues demonstrated that circulating CD34+ stem cells play a key role in HSV-associated erythema multiforme in patients without cancer. They showed that these stem cells, when infected by the virus, fragment the viral DNA and transport the HSV DNA polymerase gene, known as Pol, to distant sites in the skin.

The hallmarks of HSV-associated erythema multiforme, Dr. Aurelian said, are the presence and expression of Pol in lesional skin and in circulating CD34+ stem cells, which are increased in number in peripheral blood during acute episodes.

More recently, the investigators showed that acute GVHD of the skin following stem cell transplantation for hematologic malignancies closely resembles HSV-associated erythema multiforme clinically, histologically, and at the molecular level. In fact, acute skin GVHD is actually an erythema multiforme–reactive dermatosis involving HSV, Dr. Aurelian noted.

Clinically, acute cutaneous GVHD and HSV-associated erythema multiforme are characterized by bilaterally symmetrical, erythematous, maculopapular eruptions with a predilection for acral areas.

The minimal histopathologic criteria for acute skin GVHD also resemble those for erythema multiforme, including the finding of apoptotic cells in the epidermal basal layer, the outer root sheath of the hair follicle, and the lower malpighian layer.

In a recent study, the investigators found that lesional skin biopsies expressed Pol in 15 of 19 patients with acute skin GVHD beginning 3-15 days after stem cell transplantation, in 18 of 25 patients with HSV-associated erythema multiforme following a confirmed recurrence of HSV, and in none of 20 patients with drug-induced bullous erythema multiforme unrelated to HSV infection. None of the skin lesions from patients with GVHD or HSV-associated erythema multiforme expressed the VP5 antigen, indicating the absence of HSV viral replication.

The severity of GVHD as reflected in the amount of involved body surface area strongly correlates with the number of lesional cells expressing the Pol antigen, she added.

Dr. Aurelian proposed the following scenario regarding the pathogenesis of acute cutaneous GVHD: Patients undergoing stem cell transplant for hematologic malignancies are immunosuppressed beforehand, often resulting in reactivation of a latent HSV infection. After the stem cell transplant, a large influx of the CD34+ stem cells, which are infected by HSV, fragment HSV DNA and transport these fragments – most notably, Pol – to distant cutaneous sites. Pol expression in the skin triggers lesion development by recruiting interferon-gamma–producing virus-specific CD4+ helper T cells. An inflammatory cascade follows, and after the onset of skin lesions, a population of auto-reactive T cells accumulates.

"Basically, what begins as a viral disease turns into an autoimmune disease," the researcher explained.

Dr. Aurelian emphasized that while the skin lesions of acute GVHD contain the molecular markers of HSV-associated erythema multiforme, that’s not necessarily the case for GVHD affecting other organs.

She and her coworkers have found, for example, that intestinal biopsies obtained from patients with GVHD of the colon are consistently negative for HSV DNA fragments.

"So there is real [GVHD] in certain organs, and in our opinion there is a skin lesion that is actually an erythema multiforme reactive dermatosis associated with HSV infection," she said.

Dr. Aurelian declared having no financial conflicts of interest.

SEOUL, SOUTH KOREA – Acute cutaneous graft-versus-host disease in stem cell transplant recipients may be a manifestation of herpes simplex virus–associated erythema multiforme.

This novel hypothesis is supported by a chain of scientific evidence backed by a plausible mechanism of action, said Laure Aurelian, Ph.D., at the World Congress of Dermatology. And, if the hypothesis is correct, the implications for clinical practice will be significant.

"Viral etiology, we believe, should be seriously considered in the management of patients with graft-versus-host disease [GVHD] in the skin, because the way they are treated now – with acyclovir after stem cell transplantation has occurred – is definitely not helpful. If we are correct, then initiating the antiviral therapy earlier, and probably by IV, is the right way to go," said Dr. Aurelian of the University of Maryland, Baltimore.

After stem cell transplantation, the standard practice of initiating oral acyclovir at 800 mg twice daily starting on day 3 post procedure to preemptively quell the immunosuppression-triggered reactivation of latent herpes simplex virus (HSV) infection is too late, she said. "This standard of care is obviously not helping," given how often acute GVHD occurs.

In earlier work, Dr. Aurelian and her colleagues demonstrated that circulating CD34+ stem cells play a key role in HSV-associated erythema multiforme in patients without cancer. They showed that these stem cells, when infected by the virus, fragment the viral DNA and transport the HSV DNA polymerase gene, known as Pol, to distant sites in the skin.

The hallmarks of HSV-associated erythema multiforme, Dr. Aurelian said, are the presence and expression of Pol in lesional skin and in circulating CD34+ stem cells, which are increased in number in peripheral blood during acute episodes.

More recently, the investigators showed that acute GVHD of the skin following stem cell transplantation for hematologic malignancies closely resembles HSV-associated erythema multiforme clinically, histologically, and at the molecular level. In fact, acute skin GVHD is actually an erythema multiforme–reactive dermatosis involving HSV, Dr. Aurelian noted.

Clinically, acute cutaneous GVHD and HSV-associated erythema multiforme are characterized by bilaterally symmetrical, erythematous, maculopapular eruptions with a predilection for acral areas.

The minimal histopathologic criteria for acute skin GVHD also resemble those for erythema multiforme, including the finding of apoptotic cells in the epidermal basal layer, the outer root sheath of the hair follicle, and the lower malpighian layer.

In a recent study, the investigators found that lesional skin biopsies expressed Pol in 15 of 19 patients with acute skin GVHD beginning 3-15 days after stem cell transplantation, in 18 of 25 patients with HSV-associated erythema multiforme following a confirmed recurrence of HSV, and in none of 20 patients with drug-induced bullous erythema multiforme unrelated to HSV infection. None of the skin lesions from patients with GVHD or HSV-associated erythema multiforme expressed the VP5 antigen, indicating the absence of HSV viral replication.

The severity of GVHD as reflected in the amount of involved body surface area strongly correlates with the number of lesional cells expressing the Pol antigen, she added.

Dr. Aurelian proposed the following scenario regarding the pathogenesis of acute cutaneous GVHD: Patients undergoing stem cell transplant for hematologic malignancies are immunosuppressed beforehand, often resulting in reactivation of a latent HSV infection. After the stem cell transplant, a large influx of the CD34+ stem cells, which are infected by HSV, fragment HSV DNA and transport these fragments – most notably, Pol – to distant cutaneous sites. Pol expression in the skin triggers lesion development by recruiting interferon-gamma–producing virus-specific CD4+ helper T cells. An inflammatory cascade follows, and after the onset of skin lesions, a population of auto-reactive T cells accumulates.

"Basically, what begins as a viral disease turns into an autoimmune disease," the researcher explained.

Dr. Aurelian emphasized that while the skin lesions of acute GVHD contain the molecular markers of HSV-associated erythema multiforme, that’s not necessarily the case for GVHD affecting other organs.

She and her coworkers have found, for example, that intestinal biopsies obtained from patients with GVHD of the colon are consistently negative for HSV DNA fragments.

"So there is real [GVHD] in certain organs, and in our opinion there is a skin lesion that is actually an erythema multiforme reactive dermatosis associated with HSV infection," she said.

Dr. Aurelian declared having no financial conflicts of interest.

SEOUL, SOUTH KOREA – Acute cutaneous graft-versus-host disease in stem cell transplant recipients may be a manifestation of herpes simplex virus–associated erythema multiforme.

This novel hypothesis is supported by a chain of scientific evidence backed by a plausible mechanism of action, said Laure Aurelian, Ph.D., at the World Congress of Dermatology. And, if the hypothesis is correct, the implications for clinical practice will be significant.

"Viral etiology, we believe, should be seriously considered in the management of patients with graft-versus-host disease [GVHD] in the skin, because the way they are treated now – with acyclovir after stem cell transplantation has occurred – is definitely not helpful. If we are correct, then initiating the antiviral therapy earlier, and probably by IV, is the right way to go," said Dr. Aurelian of the University of Maryland, Baltimore.

After stem cell transplantation, the standard practice of initiating oral acyclovir at 800 mg twice daily starting on day 3 post procedure to preemptively quell the immunosuppression-triggered reactivation of latent herpes simplex virus (HSV) infection is too late, she said. "This standard of care is obviously not helping," given how often acute GVHD occurs.

In earlier work, Dr. Aurelian and her colleagues demonstrated that circulating CD34+ stem cells play a key role in HSV-associated erythema multiforme in patients without cancer. They showed that these stem cells, when infected by the virus, fragment the viral DNA and transport the HSV DNA polymerase gene, known as Pol, to distant sites in the skin.

The hallmarks of HSV-associated erythema multiforme, Dr. Aurelian said, are the presence and expression of Pol in lesional skin and in circulating CD34+ stem cells, which are increased in number in peripheral blood during acute episodes.

More recently, the investigators showed that acute GVHD of the skin following stem cell transplantation for hematologic malignancies closely resembles HSV-associated erythema multiforme clinically, histologically, and at the molecular level. In fact, acute skin GVHD is actually an erythema multiforme–reactive dermatosis involving HSV, Dr. Aurelian noted.

Clinically, acute cutaneous GVHD and HSV-associated erythema multiforme are characterized by bilaterally symmetrical, erythematous, maculopapular eruptions with a predilection for acral areas.

The minimal histopathologic criteria for acute skin GVHD also resemble those for erythema multiforme, including the finding of apoptotic cells in the epidermal basal layer, the outer root sheath of the hair follicle, and the lower malpighian layer.

In a recent study, the investigators found that lesional skin biopsies expressed Pol in 15 of 19 patients with acute skin GVHD beginning 3-15 days after stem cell transplantation, in 18 of 25 patients with HSV-associated erythema multiforme following a confirmed recurrence of HSV, and in none of 20 patients with drug-induced bullous erythema multiforme unrelated to HSV infection. None of the skin lesions from patients with GVHD or HSV-associated erythema multiforme expressed the VP5 antigen, indicating the absence of HSV viral replication.

The severity of GVHD as reflected in the amount of involved body surface area strongly correlates with the number of lesional cells expressing the Pol antigen, she added.

Dr. Aurelian proposed the following scenario regarding the pathogenesis of acute cutaneous GVHD: Patients undergoing stem cell transplant for hematologic malignancies are immunosuppressed beforehand, often resulting in reactivation of a latent HSV infection. After the stem cell transplant, a large influx of the CD34+ stem cells, which are infected by HSV, fragment HSV DNA and transport these fragments – most notably, Pol – to distant cutaneous sites. Pol expression in the skin triggers lesion development by recruiting interferon-gamma–producing virus-specific CD4+ helper T cells. An inflammatory cascade follows, and after the onset of skin lesions, a population of auto-reactive T cells accumulates.

"Basically, what begins as a viral disease turns into an autoimmune disease," the researcher explained.

Dr. Aurelian emphasized that while the skin lesions of acute GVHD contain the molecular markers of HSV-associated erythema multiforme, that’s not necessarily the case for GVHD affecting other organs.

She and her coworkers have found, for example, that intestinal biopsies obtained from patients with GVHD of the colon are consistently negative for HSV DNA fragments.

"So there is real [GVHD] in certain organs, and in our opinion there is a skin lesion that is actually an erythema multiforme reactive dermatosis associated with HSV infection," she said.

Dr. Aurelian declared having no financial conflicts of interest.

SEOUL, SOUTH KOREA – Early- and late-onset psoriasis are genetically and immunologically distinct diseases that happen to look similar clinically, according to Dr. Christopher E. Griffiths.

"All the research funding in psoriasis that has been spent in trying to understand the genetics of the disease comes down to one key finding: early-onset psoriasis, occurring before age 40, is strikingly associated with the HLA-Cw6 allele or something close to it," Dr. Griffiths said at the World Congress of Dermatology.

The class I human leukocyte antigen, HLA-Cw6, is found in 55%-80% of patients with psoriasis beginning before the age of 40. Early-onset disease accounts for 75% of all cases of psoriasis.

Late-onset psoriasis peaks in occurrence at the ages of 55-60. The frequency of the HLA-Cw6 allele in patients with late-onset disease is 15%-20%, comparable to that in the general population, said Dr. Griffiths, professor of dermatology at the University of Manchester (England).

Multiple genetic studies have shown that guttate psoriasis is predominantly found in patients who are HLA-Cw6 positive. An Icelandic study found that Cw6-positive patients also tended to have more severe psoriasis, a greater incidence of Koebner’s phenomenon, and more extensive plaques on their trunk, arms, and legs, while Cw6-negative status was associated with an increased likelihood of nail dystrophy, psoriatic arthritis, and later age of psoriasis onset (J. Invest. Dermatol. 2002;118:362-5).

Dr. Griffiths and his coworkers demonstrated that patients with early- and late-onset psoriasis also differ in terms of epidermal Langerhans cell function. These cells comprise the outermost surveillance post of the immune system. They are tasked with identifying invading pathogens and foreign antigens and transporting them from the epidermis to draining lymph nodes. Normally, this migration to lymph nodes is highly dependent upon two cytokines: interleukin-1 (IL-1) beta and tumor necrosis factor (TNF).

Dr. Griffiths and his co-investigators demonstrated that epidermal Langerhans cell mobilization and migration are greatly impaired in nonlesional skin of early-onset psoriasis patients, as compared to individuals without psoriasis.

Intradermal injection of TNF-alpha or IL-1 beta stimulated Langerhans cell migration in patients without psoriasis, but it had little or no effect on Langerhans cell function in uninvolved skin of patients with early-onset psoriasis.

In contrast, Langerhans cell migration was normal in response to intradermal injection of IL-1 beta in uninvolved skin of late-onset psoriasis patients. However, Langerhans cell migration in nonlesional skin was impaired in response to administration of TNF-alpha in the patients with late-onset psoriasis (J. Invest. Dermatol. 2010;130:1940-2).

University of Utah investigators have identified two different forms of chronic plaque psoriasis based not upon genetic or immunologic distinctions, but upon plaque morphology. In a prospective study involving 500 patients in the Utah Psoriasis Initiative, 29% of subjects characterized their plaques as thick when their psoriasis was at its most severe, while 25% rated the plaques as thin.

Thick-plaque patients were more likely to be male and have a higher body mass index, larger plaques affecting a greater body surface area, and an increased likelihood of nail dystrophy and psoriatic arthritis. Patients with thin plaques were more likely to have an eczematous component, were more prone to develop skin cancer, and were more likely to have had guttate psoriasis at some stage (J. Invest. Dermatol. 2006;126:2397-413).

"Until we understand much more about the pathogenesis and the immunology and the genetics of psoriasis, this simple clinical characterization would actually be very helpful in the clinic," said Dr. Griffiths. "I had a medical student working with me a couple of summers ago whose main task was to classify the patterns of disease in all the patients we saw in our psoriasis clinic; he could reliably differentiate 10 different forms of chronic plaque psoriasis."

Soon, it may be possible to classify plaque psoriasis by molecular phenotyping, which will help in matching the best possible treatment for a given individual, he said.

Dr. Griffiths disclosed that he has been a consultant to or has received research funds from numerous companies that manufacture drugs used in treating psoriasis.

SEOUL, SOUTH KOREA – Early- and late-onset psoriasis are genetically and immunologically distinct diseases that happen to look similar clinically, according to Dr. Christopher E. Griffiths.

"All the research funding in psoriasis that has been spent in trying to understand the genetics of the disease comes down to one key finding: early-onset psoriasis, occurring before age 40, is strikingly associated with the HLA-Cw6 allele or something close to it," Dr. Griffiths said at the World Congress of Dermatology.

The class I human leukocyte antigen, HLA-Cw6, is found in 55%-80% of patients with psoriasis beginning before the age of 40. Early-onset disease accounts for 75% of all cases of psoriasis.

Late-onset psoriasis peaks in occurrence at the ages of 55-60. The frequency of the HLA-Cw6 allele in patients with late-onset disease is 15%-20%, comparable to that in the general population, said Dr. Griffiths, professor of dermatology at the University of Manchester (England).

Multiple genetic studies have shown that guttate psoriasis is predominantly found in patients who are HLA-Cw6 positive. An Icelandic study found that Cw6-positive patients also tended to have more severe psoriasis, a greater incidence of Koebner’s phenomenon, and more extensive plaques on their trunk, arms, and legs, while Cw6-negative status was associated with an increased likelihood of nail dystrophy, psoriatic arthritis, and later age of psoriasis onset (J. Invest. Dermatol. 2002;118:362-5).

Dr. Griffiths and his coworkers demonstrated that patients with early- and late-onset psoriasis also differ in terms of epidermal Langerhans cell function. These cells comprise the outermost surveillance post of the immune system. They are tasked with identifying invading pathogens and foreign antigens and transporting them from the epidermis to draining lymph nodes. Normally, this migration to lymph nodes is highly dependent upon two cytokines: interleukin-1 (IL-1) beta and tumor necrosis factor (TNF).

Dr. Griffiths and his co-investigators demonstrated that epidermal Langerhans cell mobilization and migration are greatly impaired in nonlesional skin of early-onset psoriasis patients, as compared to individuals without psoriasis.

Intradermal injection of TNF-alpha or IL-1 beta stimulated Langerhans cell migration in patients without psoriasis, but it had little or no effect on Langerhans cell function in uninvolved skin of patients with early-onset psoriasis.

In contrast, Langerhans cell migration was normal in response to intradermal injection of IL-1 beta in uninvolved skin of late-onset psoriasis patients. However, Langerhans cell migration in nonlesional skin was impaired in response to administration of TNF-alpha in the patients with late-onset psoriasis (J. Invest. Dermatol. 2010;130:1940-2).

University of Utah investigators have identified two different forms of chronic plaque psoriasis based not upon genetic or immunologic distinctions, but upon plaque morphology. In a prospective study involving 500 patients in the Utah Psoriasis Initiative, 29% of subjects characterized their plaques as thick when their psoriasis was at its most severe, while 25% rated the plaques as thin.

Thick-plaque patients were more likely to be male and have a higher body mass index, larger plaques affecting a greater body surface area, and an increased likelihood of nail dystrophy and psoriatic arthritis. Patients with thin plaques were more likely to have an eczematous component, were more prone to develop skin cancer, and were more likely to have had guttate psoriasis at some stage (J. Invest. Dermatol. 2006;126:2397-413).

"Until we understand much more about the pathogenesis and the immunology and the genetics of psoriasis, this simple clinical characterization would actually be very helpful in the clinic," said Dr. Griffiths. "I had a medical student working with me a couple of summers ago whose main task was to classify the patterns of disease in all the patients we saw in our psoriasis clinic; he could reliably differentiate 10 different forms of chronic plaque psoriasis."

Soon, it may be possible to classify plaque psoriasis by molecular phenotyping, which will help in matching the best possible treatment for a given individual, he said.

Dr. Griffiths disclosed that he has been a consultant to or has received research funds from numerous companies that manufacture drugs used in treating psoriasis.

SEOUL, SOUTH KOREA – Early- and late-onset psoriasis are genetically and immunologically distinct diseases that happen to look similar clinically, according to Dr. Christopher E. Griffiths.

"All the research funding in psoriasis that has been spent in trying to understand the genetics of the disease comes down to one key finding: early-onset psoriasis, occurring before age 40, is strikingly associated with the HLA-Cw6 allele or something close to it," Dr. Griffiths said at the World Congress of Dermatology.

The class I human leukocyte antigen, HLA-Cw6, is found in 55%-80% of patients with psoriasis beginning before the age of 40. Early-onset disease accounts for 75% of all cases of psoriasis.

Late-onset psoriasis peaks in occurrence at the ages of 55-60. The frequency of the HLA-Cw6 allele in patients with late-onset disease is 15%-20%, comparable to that in the general population, said Dr. Griffiths, professor of dermatology at the University of Manchester (England).

Multiple genetic studies have shown that guttate psoriasis is predominantly found in patients who are HLA-Cw6 positive. An Icelandic study found that Cw6-positive patients also tended to have more severe psoriasis, a greater incidence of Koebner’s phenomenon, and more extensive plaques on their trunk, arms, and legs, while Cw6-negative status was associated with an increased likelihood of nail dystrophy, psoriatic arthritis, and later age of psoriasis onset (J. Invest. Dermatol. 2002;118:362-5).

Dr. Griffiths and his coworkers demonstrated that patients with early- and late-onset psoriasis also differ in terms of epidermal Langerhans cell function. These cells comprise the outermost surveillance post of the immune system. They are tasked with identifying invading pathogens and foreign antigens and transporting them from the epidermis to draining lymph nodes. Normally, this migration to lymph nodes is highly dependent upon two cytokines: interleukin-1 (IL-1) beta and tumor necrosis factor (TNF).

Dr. Griffiths and his co-investigators demonstrated that epidermal Langerhans cell mobilization and migration are greatly impaired in nonlesional skin of early-onset psoriasis patients, as compared to individuals without psoriasis.

Intradermal injection of TNF-alpha or IL-1 beta stimulated Langerhans cell migration in patients without psoriasis, but it had little or no effect on Langerhans cell function in uninvolved skin of patients with early-onset psoriasis.

In contrast, Langerhans cell migration was normal in response to intradermal injection of IL-1 beta in uninvolved skin of late-onset psoriasis patients. However, Langerhans cell migration in nonlesional skin was impaired in response to administration of TNF-alpha in the patients with late-onset psoriasis (J. Invest. Dermatol. 2010;130:1940-2).

University of Utah investigators have identified two different forms of chronic plaque psoriasis based not upon genetic or immunologic distinctions, but upon plaque morphology. In a prospective study involving 500 patients in the Utah Psoriasis Initiative, 29% of subjects characterized their plaques as thick when their psoriasis was at its most severe, while 25% rated the plaques as thin.

Thick-plaque patients were more likely to be male and have a higher body mass index, larger plaques affecting a greater body surface area, and an increased likelihood of nail dystrophy and psoriatic arthritis. Patients with thin plaques were more likely to have an eczematous component, were more prone to develop skin cancer, and were more likely to have had guttate psoriasis at some stage (J. Invest. Dermatol. 2006;126:2397-413).

"Until we understand much more about the pathogenesis and the immunology and the genetics of psoriasis, this simple clinical characterization would actually be very helpful in the clinic," said Dr. Griffiths. "I had a medical student working with me a couple of summers ago whose main task was to classify the patterns of disease in all the patients we saw in our psoriasis clinic; he could reliably differentiate 10 different forms of chronic plaque psoriasis."

Soon, it may be possible to classify plaque psoriasis by molecular phenotyping, which will help in matching the best possible treatment for a given individual, he said.

Dr. Griffiths disclosed that he has been a consultant to or has received research funds from numerous companies that manufacture drugs used in treating psoriasis.

SEOUL, SOUTH KOREA – Steam ablation of varicose veins appears to be a safe, effective, and relatively simple new endovascular thermal therapy with excellent patient acceptance, according to Dr. Martino Neumann.

"Maybe water will be the future for your practice," said Dr. Neumann. He presented the results of a pilot study of steam ablation at the World Congress of Dermatology.

Steam may offer a safer alternative to endovascular laser ablation of saphenous varicose veins. "If you look at your laser probe after treating a vessel, you can see strong carbonization and slight damage to the tip of the probe. This foreign material may stay within the body," said Dr. Neumann of Erasmus University Medical Center, Rotterdam, the Netherlands.

Endovascular laser ablation of varicose veins has become a popular procedure in recent years. But it results in temperatures of 600°-1,000° degrees C, causing blood to literally boil and carbonize. In contrast, steam ablation is performed at a temperature of 120° C. The pulsed steam is released under pressure into the blood vessel through two holes near the tip.

Steam ablation utilizes a 1.2-mm highly flexible catheter which is introduced directly through the puncturing needle without need for a sheath or guidewire. This makes for a simpler and safer procedure than with the stiff glass fibers used in laser ablation, said Dr. Neumann.

The pilot study entailed steam ablation of 17 great saphenous veins and 3 small saphenous veins in 19 patients. The mean treated vessel length was 25 cm, with an average of 50 steam pulses or puffs administered per treated vein. Each treated vein utilized roughly 2 mL of sterile water. The procedure was conducted on an outpatient basis under local tumescent anesthesia.

Nine patients had ecchymoses at the puncture site, and one had a transient superficial phlebitis. There were no cases of deep vein thrombosis, infection, or any other serious side effects.

All treated veins were occluded upon ultrasound examination 1 week post treatment. At 6 months follow-up, ultrasound examination showed 13 of 20 veins were completely occluded; the other 7 showed a small segment of recanalization that was not clinically relevant.

The investigators continue to search for the optimal dose of steam, expressed as puffs per treated centimeter of vein, to eliminate any recanalization.

Median patient satisfaction with the treatment was 9.25 on a 0-10 scale. Median maximal pain after the procedure was 1 on a 10-point scale.

Based upon the favorable pilot study results, a definitive head-to-head comparative study is underway. Approximately 250 patients at three Dutch medical centers were randomized to steam ablation or laser ablation; participants are now in the follow-up phase of the trial.

Studies in sheep demonstrated that the mechanism of steam ablation involves endothelial destruction, thickening of the vessel wall with fibrosis and inflammation, and alteration of collagen and elastic fibers in the media. The diameter of treated vessels decreased over time, with a mean 56% reduction 3 months post treatment.

If steam ablation is to make substantial inroads on endovascular laser ablation, it will have to be on the basis of safety, cost, and patient and operator satisfaction. Laser ablation is tough to beat on the basis of efficacy.

In a meta-analysis carried out by Dr. Neumann and coinvestigators, the 5-year success rate with endovascular laser ablation of saphenous varicose veins was 95%, compared with 80% for nonsegmental radiofrequency ablation, 74% with ultrasound-guided foam sclerotherapy, and 76% with traditional surgery involving ligation and stripping of the veins.

The steam ablation studies were conducted using the Steam Vein Sclerosis, or SVS, system manufactured by CERMA, a French company. Dr. Neumann declared having no relevant financial relationships.

SEOUL, SOUTH KOREA – Steam ablation of varicose veins appears to be a safe, effective, and relatively simple new endovascular thermal therapy with excellent patient acceptance, according to Dr. Martino Neumann.

"Maybe water will be the future for your practice," said Dr. Neumann. He presented the results of a pilot study of steam ablation at the World Congress of Dermatology.

Steam may offer a safer alternative to endovascular laser ablation of saphenous varicose veins. "If you look at your laser probe after treating a vessel, you can see strong carbonization and slight damage to the tip of the probe. This foreign material may stay within the body," said Dr. Neumann of Erasmus University Medical Center, Rotterdam, the Netherlands.

Endovascular laser ablation of varicose veins has become a popular procedure in recent years. But it results in temperatures of 600°-1,000° degrees C, causing blood to literally boil and carbonize. In contrast, steam ablation is performed at a temperature of 120° C. The pulsed steam is released under pressure into the blood vessel through two holes near the tip.

Steam ablation utilizes a 1.2-mm highly flexible catheter which is introduced directly through the puncturing needle without need for a sheath or guidewire. This makes for a simpler and safer procedure than with the stiff glass fibers used in laser ablation, said Dr. Neumann.

The pilot study entailed steam ablation of 17 great saphenous veins and 3 small saphenous veins in 19 patients. The mean treated vessel length was 25 cm, with an average of 50 steam pulses or puffs administered per treated vein. Each treated vein utilized roughly 2 mL of sterile water. The procedure was conducted on an outpatient basis under local tumescent anesthesia.

Nine patients had ecchymoses at the puncture site, and one had a transient superficial phlebitis. There were no cases of deep vein thrombosis, infection, or any other serious side effects.

All treated veins were occluded upon ultrasound examination 1 week post treatment. At 6 months follow-up, ultrasound examination showed 13 of 20 veins were completely occluded; the other 7 showed a small segment of recanalization that was not clinically relevant.

The investigators continue to search for the optimal dose of steam, expressed as puffs per treated centimeter of vein, to eliminate any recanalization.

Median patient satisfaction with the treatment was 9.25 on a 0-10 scale. Median maximal pain after the procedure was 1 on a 10-point scale.

Based upon the favorable pilot study results, a definitive head-to-head comparative study is underway. Approximately 250 patients at three Dutch medical centers were randomized to steam ablation or laser ablation; participants are now in the follow-up phase of the trial.

Studies in sheep demonstrated that the mechanism of steam ablation involves endothelial destruction, thickening of the vessel wall with fibrosis and inflammation, and alteration of collagen and elastic fibers in the media. The diameter of treated vessels decreased over time, with a mean 56% reduction 3 months post treatment.

If steam ablation is to make substantial inroads on endovascular laser ablation, it will have to be on the basis of safety, cost, and patient and operator satisfaction. Laser ablation is tough to beat on the basis of efficacy.

In a meta-analysis carried out by Dr. Neumann and coinvestigators, the 5-year success rate with endovascular laser ablation of saphenous varicose veins was 95%, compared with 80% for nonsegmental radiofrequency ablation, 74% with ultrasound-guided foam sclerotherapy, and 76% with traditional surgery involving ligation and stripping of the veins.

The steam ablation studies were conducted using the Steam Vein Sclerosis, or SVS, system manufactured by CERMA, a French company. Dr. Neumann declared having no relevant financial relationships.

SEOUL, SOUTH KOREA – Steam ablation of varicose veins appears to be a safe, effective, and relatively simple new endovascular thermal therapy with excellent patient acceptance, according to Dr. Martino Neumann.

"Maybe water will be the future for your practice," said Dr. Neumann. He presented the results of a pilot study of steam ablation at the World Congress of Dermatology.

Steam may offer a safer alternative to endovascular laser ablation of saphenous varicose veins. "If you look at your laser probe after treating a vessel, you can see strong carbonization and slight damage to the tip of the probe. This foreign material may stay within the body," said Dr. Neumann of Erasmus University Medical Center, Rotterdam, the Netherlands.

Endovascular laser ablation of varicose veins has become a popular procedure in recent years. But it results in temperatures of 600°-1,000° degrees C, causing blood to literally boil and carbonize. In contrast, steam ablation is performed at a temperature of 120° C. The pulsed steam is released under pressure into the blood vessel through two holes near the tip.

Steam ablation utilizes a 1.2-mm highly flexible catheter which is introduced directly through the puncturing needle without need for a sheath or guidewire. This makes for a simpler and safer procedure than with the stiff glass fibers used in laser ablation, said Dr. Neumann.

The pilot study entailed steam ablation of 17 great saphenous veins and 3 small saphenous veins in 19 patients. The mean treated vessel length was 25 cm, with an average of 50 steam pulses or puffs administered per treated vein. Each treated vein utilized roughly 2 mL of sterile water. The procedure was conducted on an outpatient basis under local tumescent anesthesia.

Nine patients had ecchymoses at the puncture site, and one had a transient superficial phlebitis. There were no cases of deep vein thrombosis, infection, or any other serious side effects.

All treated veins were occluded upon ultrasound examination 1 week post treatment. At 6 months follow-up, ultrasound examination showed 13 of 20 veins were completely occluded; the other 7 showed a small segment of recanalization that was not clinically relevant.

The investigators continue to search for the optimal dose of steam, expressed as puffs per treated centimeter of vein, to eliminate any recanalization.

Median patient satisfaction with the treatment was 9.25 on a 0-10 scale. Median maximal pain after the procedure was 1 on a 10-point scale.

Based upon the favorable pilot study results, a definitive head-to-head comparative study is underway. Approximately 250 patients at three Dutch medical centers were randomized to steam ablation or laser ablation; participants are now in the follow-up phase of the trial.

Studies in sheep demonstrated that the mechanism of steam ablation involves endothelial destruction, thickening of the vessel wall with fibrosis and inflammation, and alteration of collagen and elastic fibers in the media. The diameter of treated vessels decreased over time, with a mean 56% reduction 3 months post treatment.

If steam ablation is to make substantial inroads on endovascular laser ablation, it will have to be on the basis of safety, cost, and patient and operator satisfaction. Laser ablation is tough to beat on the basis of efficacy.

In a meta-analysis carried out by Dr. Neumann and coinvestigators, the 5-year success rate with endovascular laser ablation of saphenous varicose veins was 95%, compared with 80% for nonsegmental radiofrequency ablation, 74% with ultrasound-guided foam sclerotherapy, and 76% with traditional surgery involving ligation and stripping of the veins.

The steam ablation studies were conducted using the Steam Vein Sclerosis, or SVS, system manufactured by CERMA, a French company. Dr. Neumann declared having no relevant financial relationships.

SEOUL, SOUTH KOREA – Alefacept in combination with narrow-band UVB was found to be more effective than alefacept monotherapy, as demonstrated in the Canadian Alefacept Phototherapy Psoriasis Study.

The combination therapy group had a PASI 75 response rate twice that seen with alefacept (Amevive) monotherapy, along with impressively long improvement after completing a 12-week course of treatment, Dr. Wayne Gulliver said at the World Congress of Dermatology.

"I think the value of this combination is you get sustained improvement for many weeks and months off therapy," he observed. "I have some patients who take a course every 2 years, and they're happy with that."

The multicenter, open-label, blinded-assessment Canadian clinical trial involved 98 patients with moderate to severe chronic plaque psoriasis who were randomized to alefacept 15 mg IM once weekly alone or in combination with narrow-band UVB phototherapy thrice weekly for 12 weeks, followed by a 24-week observation period.

The primary outcome measure was a PASI 75 response at week 16. This occurred in 45% of patients receiving combination therapy, compared with 22% receiving alefacept monotherapy, according to Dr. Gulliver, professor of dermatology and chairman of medicine at Memorial University of Newfoundland, St. John's.

Ten patients in the dual-therapy group achieved a PASI 90 response at week 16, compared with 4 on alefacept alone. Twenty-nine patients in the combination treatment arm were rated as clear or almost clear by Physician's Global Assessment at any time during the study, compared with 17 patients on monotherapy.

PASI 50 and PASI 75 improvements often occurred several months earlier with alefacept plus narrow-band UVB. The combination was "extremely well tolerated," with a side-effect profile quite similar to that of alefacept alone, he said.

He added that he considers this combination especially useful in patients who have failed numerous other potent therapies. "This gives us one more option for patients who really are running out of options," Dr. Gulliver said.

The other situation in which he finds alefacept in combination with narrow-band UVB particularly advantageous is for patients who would like to be off of systemic therapy for a long while, such as women who are interested in having a baby.

Dr. Gulliver disclosed that has been a consultant to and/or has been paid for clinical trials for 20 pharmaceutical companies, including Astellas Pharma Canada, which markets alefacept.

SEOUL, SOUTH KOREA – Alefacept in combination with narrow-band UVB was found to be more effective than alefacept monotherapy, as demonstrated in the Canadian Alefacept Phototherapy Psoriasis Study.

The combination therapy group had a PASI 75 response rate twice that seen with alefacept (Amevive) monotherapy, along with impressively long improvement after completing a 12-week course of treatment, Dr. Wayne Gulliver said at the World Congress of Dermatology.

"I think the value of this combination is you get sustained improvement for many weeks and months off therapy," he observed. "I have some patients who take a course every 2 years, and they're happy with that."

The multicenter, open-label, blinded-assessment Canadian clinical trial involved 98 patients with moderate to severe chronic plaque psoriasis who were randomized to alefacept 15 mg IM once weekly alone or in combination with narrow-band UVB phototherapy thrice weekly for 12 weeks, followed by a 24-week observation period.

The primary outcome measure was a PASI 75 response at week 16. This occurred in 45% of patients receiving combination therapy, compared with 22% receiving alefacept monotherapy, according to Dr. Gulliver, professor of dermatology and chairman of medicine at Memorial University of Newfoundland, St. John's.

Ten patients in the dual-therapy group achieved a PASI 90 response at week 16, compared with 4 on alefacept alone. Twenty-nine patients in the combination treatment arm were rated as clear or almost clear by Physician's Global Assessment at any time during the study, compared with 17 patients on monotherapy.

PASI 50 and PASI 75 improvements often occurred several months earlier with alefacept plus narrow-band UVB. The combination was "extremely well tolerated," with a side-effect profile quite similar to that of alefacept alone, he said.

He added that he considers this combination especially useful in patients who have failed numerous other potent therapies. "This gives us one more option for patients who really are running out of options," Dr. Gulliver said.

The other situation in which he finds alefacept in combination with narrow-band UVB particularly advantageous is for patients who would like to be off of systemic therapy for a long while, such as women who are interested in having a baby.

Dr. Gulliver disclosed that has been a consultant to and/or has been paid for clinical trials for 20 pharmaceutical companies, including Astellas Pharma Canada, which markets alefacept.

SEOUL, SOUTH KOREA – Alefacept in combination with narrow-band UVB was found to be more effective than alefacept monotherapy, as demonstrated in the Canadian Alefacept Phototherapy Psoriasis Study.

The combination therapy group had a PASI 75 response rate twice that seen with alefacept (Amevive) monotherapy, along with impressively long improvement after completing a 12-week course of treatment, Dr. Wayne Gulliver said at the World Congress of Dermatology.

"I think the value of this combination is you get sustained improvement for many weeks and months off therapy," he observed. "I have some patients who take a course every 2 years, and they're happy with that."

The multicenter, open-label, blinded-assessment Canadian clinical trial involved 98 patients with moderate to severe chronic plaque psoriasis who were randomized to alefacept 15 mg IM once weekly alone or in combination with narrow-band UVB phototherapy thrice weekly for 12 weeks, followed by a 24-week observation period.

The primary outcome measure was a PASI 75 response at week 16. This occurred in 45% of patients receiving combination therapy, compared with 22% receiving alefacept monotherapy, according to Dr. Gulliver, professor of dermatology and chairman of medicine at Memorial University of Newfoundland, St. John's.

Ten patients in the dual-therapy group achieved a PASI 90 response at week 16, compared with 4 on alefacept alone. Twenty-nine patients in the combination treatment arm were rated as clear or almost clear by Physician's Global Assessment at any time during the study, compared with 17 patients on monotherapy.

PASI 50 and PASI 75 improvements often occurred several months earlier with alefacept plus narrow-band UVB. The combination was "extremely well tolerated," with a side-effect profile quite similar to that of alefacept alone, he said.

He added that he considers this combination especially useful in patients who have failed numerous other potent therapies. "This gives us one more option for patients who really are running out of options," Dr. Gulliver said.

The other situation in which he finds alefacept in combination with narrow-band UVB particularly advantageous is for patients who would like to be off of systemic therapy for a long while, such as women who are interested in having a baby.

Dr. Gulliver disclosed that has been a consultant to and/or has been paid for clinical trials for 20 pharmaceutical companies, including Astellas Pharma Canada, which markets alefacept.

SEOUL, SOUTH KOREA – New evidence indicates that an important cause of extrinsic skin aging is chronic exposure to soot and other airborne particulates generated by motor vehicle exhaust.

A strong epidemiologic association has been established between residing near a busy highway and increased skin wrinkling and pigmented spots, and a plausible biologic mechanism for causality has been established. Thus, exposure to traffic-related airborne particulate matter joins solar ultraviolet radiation and tobacco smoke as the third potentially modifiable major factor identified in extrinsic skin aging, Dr. Jean Krutmann said at the World Congress of Dermatology.

Photo credit: Sergiy Serdyuk/ISTOCKPHOTO.COM

"My first major message is that nanoparticles are present in ambient air and represent a novel threat to human skin," said Dr. Krutmann, professor of dermatology and environmental health medicine at Heinrich Heine University in Düsseldorf, Germany.

He and his coinvestigators have shown that the threat is more than skin deep.

They have previously linked chronic exposure to traffic-related fine particulate polyaromatic hydrocarbons with a diverse group of other major adverse health effects in addition to skin aging.

They have shown that at one end of the life span, such exposure impairs cognitive function in the elderly (Environ. Res. 2009;109:1,004-11); ongoing prospective studies will determine whether this exposure is also involved in the pathogenesis of Alzheimer's disease.

The same landmark German epidemiologic study that linked airborne particle exposure to mild cognitive impairment – the Study on the Influence of Air Pollution on Lung Function, Inflammation, and Aging (SALIA) – has implicated exposure to traffic-related particulate matter with increased risk of type 2 diabetes (Environ. Health Perspect. 2010;118:1,273-9).

SALIA involved close to 5,000 German women who were enrolled in the mid-1980s, when they were on average 55 years old, and who have been followed for 20 years. Participants were drawn from a heavily industrialized area of Germany as well as from low-pollution rural districts.

At the other end of the life span, Dr. Krutmann and his coinvestigators have demonstrated in prospective studies of 3,390 small-town German newborns followed to age 6 years that exposure to traffic-related airborne particulates was related in dose-response fashion to longer duration of eczema (J. Dermatol. Sci. 2009;56:99-105).

How could sooty air pollution due to incomplete combustion be involved in the pathogenesis of neurodegenerative diseases and type 2 diabetes? Animal studies demonstrate that once these fine airborne particles get into the upper respiratory tract, they can move on to the systemic circulation and exert direct inflammatory effects in other organs – including the brain and pancreas, the dermatologist explained.

The skin aging study was conducted in 400 German women aged 70-80 years who were randomly drawn from the SALIA cohort. The extent of their skin aging was assessed by means of the well-validated Score of Intrinsic and Extrinsic Skin Aging (SCINEXA). Air pollution exposure was determined by the distance between a participant’s home and the nearest major roadway with a traffic volume in excess of 10,000 vehicles per day, as well as by measurement of ambient particulate matter less than 10 mcm in diameter at fixed monitoring sites.

Air pollution exposure proved to be related in dose-response fashion to an increase in pigmented spots on the cheeks and forehead, as well as to facial wrinkles (J. Invest. Dermatol. 2010;130:2,719-26).

Dr. Krutmann said that as a nonepidemiologist, he needs to understand the potential biologic mechanism underlying an epidemiologic observation before he can accept it. He and his colleagues have recently developed such persuasive evidence through animal and in vitro human skin studies.

They have shown that the polyaromatic hydrocarbons in traffic soot activate the aryl hydrocarbon receptor (AhR) expressed on keratinocytes and melanocytes. This results in increased matrix metalloproteinase-1 activity, which in turn leads to degradation of collagen in the dermal matrix and thereby to formation of wrinkles. Activation of the AhR also stimulates melanocyte proliferation, which would explain the increased formation of pigmented spots (J. Invest. Dermatol. 2011;131:203-10).

The clinical implication of these findings is that inhibition of the AhR in skin may be a novel strategy for prevention of extrinsic skin aging. Dr. Krutmann disclosed that he is working with Symrise, a German chemical company, to develop AhR antagonists suitable for topical application in cosmetics. One such product, SymHelios 1031, is already in commercial use.

SALIA and the pediatric eczema studies were funded by the German government.

SEOUL, SOUTH KOREA – New evidence indicates that an important cause of extrinsic skin aging is chronic exposure to soot and other airborne particulates generated by motor vehicle exhaust.

A strong epidemiologic association has been established between residing near a busy highway and increased skin wrinkling and pigmented spots, and a plausible biologic mechanism for causality has been established. Thus, exposure to traffic-related airborne particulate matter joins solar ultraviolet radiation and tobacco smoke as the third potentially modifiable major factor identified in extrinsic skin aging, Dr. Jean Krutmann said at the World Congress of Dermatology.

Photo credit: Sergiy Serdyuk/ISTOCKPHOTO.COM

"My first major message is that nanoparticles are present in ambient air and represent a novel threat to human skin," said Dr. Krutmann, professor of dermatology and environmental health medicine at Heinrich Heine University in Düsseldorf, Germany.

He and his coinvestigators have shown that the threat is more than skin deep.

They have previously linked chronic exposure to traffic-related fine particulate polyaromatic hydrocarbons with a diverse group of other major adverse health effects in addition to skin aging.

They have shown that at one end of the life span, such exposure impairs cognitive function in the elderly (Environ. Res. 2009;109:1,004-11); ongoing prospective studies will determine whether this exposure is also involved in the pathogenesis of Alzheimer's disease.

The same landmark German epidemiologic study that linked airborne particle exposure to mild cognitive impairment – the Study on the Influence of Air Pollution on Lung Function, Inflammation, and Aging (SALIA) – has implicated exposure to traffic-related particulate matter with increased risk of type 2 diabetes (Environ. Health Perspect. 2010;118:1,273-9).

SALIA involved close to 5,000 German women who were enrolled in the mid-1980s, when they were on average 55 years old, and who have been followed for 20 years. Participants were drawn from a heavily industrialized area of Germany as well as from low-pollution rural districts.

At the other end of the life span, Dr. Krutmann and his coinvestigators have demonstrated in prospective studies of 3,390 small-town German newborns followed to age 6 years that exposure to traffic-related airborne particulates was related in dose-response fashion to longer duration of eczema (J. Dermatol. Sci. 2009;56:99-105).

How could sooty air pollution due to incomplete combustion be involved in the pathogenesis of neurodegenerative diseases and type 2 diabetes? Animal studies demonstrate that once these fine airborne particles get into the upper respiratory tract, they can move on to the systemic circulation and exert direct inflammatory effects in other organs – including the brain and pancreas, the dermatologist explained.

The skin aging study was conducted in 400 German women aged 70-80 years who were randomly drawn from the SALIA cohort. The extent of their skin aging was assessed by means of the well-validated Score of Intrinsic and Extrinsic Skin Aging (SCINEXA). Air pollution exposure was determined by the distance between a participant’s home and the nearest major roadway with a traffic volume in excess of 10,000 vehicles per day, as well as by measurement of ambient particulate matter less than 10 mcm in diameter at fixed monitoring sites.

Air pollution exposure proved to be related in dose-response fashion to an increase in pigmented spots on the cheeks and forehead, as well as to facial wrinkles (J. Invest. Dermatol. 2010;130:2,719-26).

Dr. Krutmann said that as a nonepidemiologist, he needs to understand the potential biologic mechanism underlying an epidemiologic observation before he can accept it. He and his colleagues have recently developed such persuasive evidence through animal and in vitro human skin studies.

They have shown that the polyaromatic hydrocarbons in traffic soot activate the aryl hydrocarbon receptor (AhR) expressed on keratinocytes and melanocytes. This results in increased matrix metalloproteinase-1 activity, which in turn leads to degradation of collagen in the dermal matrix and thereby to formation of wrinkles. Activation of the AhR also stimulates melanocyte proliferation, which would explain the increased formation of pigmented spots (J. Invest. Dermatol. 2011;131:203-10).

The clinical implication of these findings is that inhibition of the AhR in skin may be a novel strategy for prevention of extrinsic skin aging. Dr. Krutmann disclosed that he is working with Symrise, a German chemical company, to develop AhR antagonists suitable for topical application in cosmetics. One such product, SymHelios 1031, is already in commercial use.

SALIA and the pediatric eczema studies were funded by the German government.

SEOUL, SOUTH KOREA – New evidence indicates that an important cause of extrinsic skin aging is chronic exposure to soot and other airborne particulates generated by motor vehicle exhaust.

A strong epidemiologic association has been established between residing near a busy highway and increased skin wrinkling and pigmented spots, and a plausible biologic mechanism for causality has been established. Thus, exposure to traffic-related airborne particulate matter joins solar ultraviolet radiation and tobacco smoke as the third potentially modifiable major factor identified in extrinsic skin aging, Dr. Jean Krutmann said at the World Congress of Dermatology.

Photo credit: Sergiy Serdyuk/ISTOCKPHOTO.COM

"My first major message is that nanoparticles are present in ambient air and represent a novel threat to human skin," said Dr. Krutmann, professor of dermatology and environmental health medicine at Heinrich Heine University in Düsseldorf, Germany.

He and his coinvestigators have shown that the threat is more than skin deep.

They have previously linked chronic exposure to traffic-related fine particulate polyaromatic hydrocarbons with a diverse group of other major adverse health effects in addition to skin aging.

They have shown that at one end of the life span, such exposure impairs cognitive function in the elderly (Environ. Res. 2009;109:1,004-11); ongoing prospective studies will determine whether this exposure is also involved in the pathogenesis of Alzheimer's disease.

The same landmark German epidemiologic study that linked airborne particle exposure to mild cognitive impairment – the Study on the Influence of Air Pollution on Lung Function, Inflammation, and Aging (SALIA) – has implicated exposure to traffic-related particulate matter with increased risk of type 2 diabetes (Environ. Health Perspect. 2010;118:1,273-9).

SALIA involved close to 5,000 German women who were enrolled in the mid-1980s, when they were on average 55 years old, and who have been followed for 20 years. Participants were drawn from a heavily industrialized area of Germany as well as from low-pollution rural districts.

At the other end of the life span, Dr. Krutmann and his coinvestigators have demonstrated in prospective studies of 3,390 small-town German newborns followed to age 6 years that exposure to traffic-related airborne particulates was related in dose-response fashion to longer duration of eczema (J. Dermatol. Sci. 2009;56:99-105).

How could sooty air pollution due to incomplete combustion be involved in the pathogenesis of neurodegenerative diseases and type 2 diabetes? Animal studies demonstrate that once these fine airborne particles get into the upper respiratory tract, they can move on to the systemic circulation and exert direct inflammatory effects in other organs – including the brain and pancreas, the dermatologist explained.

The skin aging study was conducted in 400 German women aged 70-80 years who were randomly drawn from the SALIA cohort. The extent of their skin aging was assessed by means of the well-validated Score of Intrinsic and Extrinsic Skin Aging (SCINEXA). Air pollution exposure was determined by the distance between a participant’s home and the nearest major roadway with a traffic volume in excess of 10,000 vehicles per day, as well as by measurement of ambient particulate matter less than 10 mcm in diameter at fixed monitoring sites.

Air pollution exposure proved to be related in dose-response fashion to an increase in pigmented spots on the cheeks and forehead, as well as to facial wrinkles (J. Invest. Dermatol. 2010;130:2,719-26).

Dr. Krutmann said that as a nonepidemiologist, he needs to understand the potential biologic mechanism underlying an epidemiologic observation before he can accept it. He and his colleagues have recently developed such persuasive evidence through animal and in vitro human skin studies.

They have shown that the polyaromatic hydrocarbons in traffic soot activate the aryl hydrocarbon receptor (AhR) expressed on keratinocytes and melanocytes. This results in increased matrix metalloproteinase-1 activity, which in turn leads to degradation of collagen in the dermal matrix and thereby to formation of wrinkles. Activation of the AhR also stimulates melanocyte proliferation, which would explain the increased formation of pigmented spots (J. Invest. Dermatol. 2011;131:203-10).

The clinical implication of these findings is that inhibition of the AhR in skin may be a novel strategy for prevention of extrinsic skin aging. Dr. Krutmann disclosed that he is working with Symrise, a German chemical company, to develop AhR antagonists suitable for topical application in cosmetics. One such product, SymHelios 1031, is already in commercial use.

SALIA and the pediatric eczema studies were funded by the German government.

SEOUL, SOUTH KOREA – The 5% minoxidil foam approved for treatment of male androgenetic alopecia demonstrated significant clinical advantages over 2% minoxidil topical solution in the first head-to-head comparative trial conducted in women with the hair disorder.

The 5% minoxidil foam is approved as once-daily therapy in men only. The twice-daily 2% topical solution is the sole medication approved in the United States and Europe for female androgenetic alopecia. But in the randomized trial, the once-daily 5% foam earned higher marks from women in terms of cosmetic acceptance, convenience, and tolerability while demonstrating efficacy similar to that of the twice-daily 2% solution, Dr. Ulrike Blume-Peytavi reported at the World Congress of Dermatology.

She presented a 24-week, investigator-blinded, prospective, multicenter, randomized trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in 113 patients with female-pattern hair loss. The primary end point was the change from baseline to week 24 in terms of nonvellus target-area hair count as measured by Canfield hair matrix image analysis.

Patients assigned to the 5% foam had a mean 32-hair/cm² or 16% increase, not significantly different from the 14% increase documented in women on the 2% topical solution.

In terms of secondary end points, global photographic review by blinded expert evaluators rated 68% of women in the 5% foam group as having achieved increased hair volume, and a similar 56% of those who received the 2% solution. Nor were the subjects' own efficacy ratings significantly different between the two groups, according to Dr. Blume-Peytavi of the Clinical Research Center for Hair and Skin Science at Charité University, Berlin.

Women randomized to 5% minoxidil foam experienced significantly lower rates of treatment intolerance, particularly with regard to itching and dandruff. Sixteen percent of them reported significant pruritus, compared with 39% of women on the 2% minoxidil solution. Just 5% of the women on the 5% minoxidil foam complained of dandruff, compared with 18% on the 2% solution. There were, however, no significant differences between the study arms in terms of complaints of redness, stinging, or dryness.

On a cosmetic acceptability questionnaire, 46% of the 5% minoxidil foam group strongly indicated that the medication did not interfere with styling their hair, compared with just 19% of women on the 2% topical solution.

The reason Dr. Blume-Peytavi and coinvestigators undertook this trial was to test their hypothesis that the minoxidil foam would be better tolerated and more cosmetically acceptable because, unlike the 2% topical solution, it is free of propylene glycol. They also thought the foam product would be significantly more effective at stimulating new hair growth because of its higher minoxidil concentration, although this proved not to be the case.

Dr. Blume-Peytavi is a consultant to Johnson & Johnson and Procter & Gamble.

SEOUL, SOUTH KOREA – The 5% minoxidil foam approved for treatment of male androgenetic alopecia demonstrated significant clinical advantages over 2% minoxidil topical solution in the first head-to-head comparative trial conducted in women with the hair disorder.

The 5% minoxidil foam is approved as once-daily therapy in men only. The twice-daily 2% topical solution is the sole medication approved in the United States and Europe for female androgenetic alopecia. But in the randomized trial, the once-daily 5% foam earned higher marks from women in terms of cosmetic acceptance, convenience, and tolerability while demonstrating efficacy similar to that of the twice-daily 2% solution, Dr. Ulrike Blume-Peytavi reported at the World Congress of Dermatology.

She presented a 24-week, investigator-blinded, prospective, multicenter, randomized trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in 113 patients with female-pattern hair loss. The primary end point was the change from baseline to week 24 in terms of nonvellus target-area hair count as measured by Canfield hair matrix image analysis.

Patients assigned to the 5% foam had a mean 32-hair/cm² or 16% increase, not significantly different from the 14% increase documented in women on the 2% topical solution.

In terms of secondary end points, global photographic review by blinded expert evaluators rated 68% of women in the 5% foam group as having achieved increased hair volume, and a similar 56% of those who received the 2% solution. Nor were the subjects' own efficacy ratings significantly different between the two groups, according to Dr. Blume-Peytavi of the Clinical Research Center for Hair and Skin Science at Charité University, Berlin.

Women randomized to 5% minoxidil foam experienced significantly lower rates of treatment intolerance, particularly with regard to itching and dandruff. Sixteen percent of them reported significant pruritus, compared with 39% of women on the 2% minoxidil solution. Just 5% of the women on the 5% minoxidil foam complained of dandruff, compared with 18% on the 2% solution. There were, however, no significant differences between the study arms in terms of complaints of redness, stinging, or dryness.

On a cosmetic acceptability questionnaire, 46% of the 5% minoxidil foam group strongly indicated that the medication did not interfere with styling their hair, compared with just 19% of women on the 2% topical solution.

The reason Dr. Blume-Peytavi and coinvestigators undertook this trial was to test their hypothesis that the minoxidil foam would be better tolerated and more cosmetically acceptable because, unlike the 2% topical solution, it is free of propylene glycol. They also thought the foam product would be significantly more effective at stimulating new hair growth because of its higher minoxidil concentration, although this proved not to be the case.

Dr. Blume-Peytavi is a consultant to Johnson & Johnson and Procter & Gamble.

SEOUL, SOUTH KOREA – The 5% minoxidil foam approved for treatment of male androgenetic alopecia demonstrated significant clinical advantages over 2% minoxidil topical solution in the first head-to-head comparative trial conducted in women with the hair disorder.

The 5% minoxidil foam is approved as once-daily therapy in men only. The twice-daily 2% topical solution is the sole medication approved in the United States and Europe for female androgenetic alopecia. But in the randomized trial, the once-daily 5% foam earned higher marks from women in terms of cosmetic acceptance, convenience, and tolerability while demonstrating efficacy similar to that of the twice-daily 2% solution, Dr. Ulrike Blume-Peytavi reported at the World Congress of Dermatology.

She presented a 24-week, investigator-blinded, prospective, multicenter, randomized trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in 113 patients with female-pattern hair loss. The primary end point was the change from baseline to week 24 in terms of nonvellus target-area hair count as measured by Canfield hair matrix image analysis.

Patients assigned to the 5% foam had a mean 32-hair/cm² or 16% increase, not significantly different from the 14% increase documented in women on the 2% topical solution.

In terms of secondary end points, global photographic review by blinded expert evaluators rated 68% of women in the 5% foam group as having achieved increased hair volume, and a similar 56% of those who received the 2% solution. Nor were the subjects' own efficacy ratings significantly different between the two groups, according to Dr. Blume-Peytavi of the Clinical Research Center for Hair and Skin Science at Charité University, Berlin.

Women randomized to 5% minoxidil foam experienced significantly lower rates of treatment intolerance, particularly with regard to itching and dandruff. Sixteen percent of them reported significant pruritus, compared with 39% of women on the 2% minoxidil solution. Just 5% of the women on the 5% minoxidil foam complained of dandruff, compared with 18% on the 2% solution. There were, however, no significant differences between the study arms in terms of complaints of redness, stinging, or dryness.

On a cosmetic acceptability questionnaire, 46% of the 5% minoxidil foam group strongly indicated that the medication did not interfere with styling their hair, compared with just 19% of women on the 2% topical solution.

The reason Dr. Blume-Peytavi and coinvestigators undertook this trial was to test their hypothesis that the minoxidil foam would be better tolerated and more cosmetically acceptable because, unlike the 2% topical solution, it is free of propylene glycol. They also thought the foam product would be significantly more effective at stimulating new hair growth because of its higher minoxidil concentration, although this proved not to be the case.

Dr. Blume-Peytavi is a consultant to Johnson & Johnson and Procter & Gamble.

SEOUL, SOUTH KOREA – The combination of calcipotriene and nicotinamide may be an attractive corticosteroid-sparing option for topical psoriasis therapy, according to results from a pilot trial.

"Both agents are somewhat effective for psoriasis; the combination of the two is markedly superior," Dr. Mark Lebwohl said in summarizing the findings of a pilot bilateral comparative study presented at the World Congress of Dermatology.

The investigational topical combination therapy is being developed by Dermipsor, an Israeli pharmaceutical company.

Dr. Lebwohl was a coinvestigator in the multicenter, double-blind, 12-week pilot study involving 168 patients with symmetric moderate psoriasis (defined as not more than 15% body surface area involvement).

The patients were randomized to two of seven treatments: calcipotriene 0.005% monotherapy, nicotinamide 1.4% alone, placebo, or calcipotriene 0.005% plus nicotinamide in a concentration of either 0.05%, 0.1%, 0.7%, or 1.4%. Patients treated the lesions on one side of the body with one of their two assigned treatments, and lesions on the opposite side with the other.

The primary end point was efficacy (defined as a clear to almost-clear outcome at week 12), which was achieved in 19% of patients who were treated with placebo, 25% of those on nicotinamide 1.4% alone, 31.5% of those treated with calcipotriene alone, and 50% of patients in the calcipotriene plus nicotinamide 1.4% group, reported Dr. Lebwohl, professor and chairman of the department of dermatology at Mount Sinai School of Medicine, New York.

The 50% clear or almost-clear rate with calcipotriene plus nicotinamide 1.4% is similar to the 48% rate of absent to very mild disease that was previously reported with a calcipotriol/betamethasone combination in a 52-week study (Dermatology 2006;213:319-26).

Thus, the calcipotriene/nicotinamide combination is an agent that will be investigated further in larger, lengthier studies as a possible steroid-sparing agent in comparative trials vs. calcipotriene-steroid combination therapy, Dr. Lebwohl said.

Topical combination therapy continues to be an active area in psoriasis research, he observed.

"It’s really a no-brainer: The combination of two ingredients is going to be superior to either one alone. It’s a very simple concept: Two is better than one," he said.

Dr. Lebwohl disclosed that he is a consultant to Dermipsor and has advisory board relationships with other pharmaceutical companies that are developing dermatologic drugs.

SEOUL, SOUTH KOREA – The combination of calcipotriene and nicotinamide may be an attractive corticosteroid-sparing option for topical psoriasis therapy, according to results from a pilot trial.

"Both agents are somewhat effective for psoriasis; the combination of the two is markedly superior," Dr. Mark Lebwohl said in summarizing the findings of a pilot bilateral comparative study presented at the World Congress of Dermatology.

The investigational topical combination therapy is being developed by Dermipsor, an Israeli pharmaceutical company.

Dr. Lebwohl was a coinvestigator in the multicenter, double-blind, 12-week pilot study involving 168 patients with symmetric moderate psoriasis (defined as not more than 15% body surface area involvement).

The patients were randomized to two of seven treatments: calcipotriene 0.005% monotherapy, nicotinamide 1.4% alone, placebo, or calcipotriene 0.005% plus nicotinamide in a concentration of either 0.05%, 0.1%, 0.7%, or 1.4%. Patients treated the lesions on one side of the body with one of their two assigned treatments, and lesions on the opposite side with the other.

The primary end point was efficacy (defined as a clear to almost-clear outcome at week 12), which was achieved in 19% of patients who were treated with placebo, 25% of those on nicotinamide 1.4% alone, 31.5% of those treated with calcipotriene alone, and 50% of patients in the calcipotriene plus nicotinamide 1.4% group, reported Dr. Lebwohl, professor and chairman of the department of dermatology at Mount Sinai School of Medicine, New York.

The 50% clear or almost-clear rate with calcipotriene plus nicotinamide 1.4% is similar to the 48% rate of absent to very mild disease that was previously reported with a calcipotriol/betamethasone combination in a 52-week study (Dermatology 2006;213:319-26).

Thus, the calcipotriene/nicotinamide combination is an agent that will be investigated further in larger, lengthier studies as a possible steroid-sparing agent in comparative trials vs. calcipotriene-steroid combination therapy, Dr. Lebwohl said.

Topical combination therapy continues to be an active area in psoriasis research, he observed.

"It’s really a no-brainer: The combination of two ingredients is going to be superior to either one alone. It’s a very simple concept: Two is better than one," he said.

Dr. Lebwohl disclosed that he is a consultant to Dermipsor and has advisory board relationships with other pharmaceutical companies that are developing dermatologic drugs.

SEOUL, SOUTH KOREA – The combination of calcipotriene and nicotinamide may be an attractive corticosteroid-sparing option for topical psoriasis therapy, according to results from a pilot trial.

"Both agents are somewhat effective for psoriasis; the combination of the two is markedly superior," Dr. Mark Lebwohl said in summarizing the findings of a pilot bilateral comparative study presented at the World Congress of Dermatology.

The investigational topical combination therapy is being developed by Dermipsor, an Israeli pharmaceutical company.

Dr. Lebwohl was a coinvestigator in the multicenter, double-blind, 12-week pilot study involving 168 patients with symmetric moderate psoriasis (defined as not more than 15% body surface area involvement).

The patients were randomized to two of seven treatments: calcipotriene 0.005% monotherapy, nicotinamide 1.4% alone, placebo, or calcipotriene 0.005% plus nicotinamide in a concentration of either 0.05%, 0.1%, 0.7%, or 1.4%. Patients treated the lesions on one side of the body with one of their two assigned treatments, and lesions on the opposite side with the other.

The primary end point was efficacy (defined as a clear to almost-clear outcome at week 12), which was achieved in 19% of patients who were treated with placebo, 25% of those on nicotinamide 1.4% alone, 31.5% of those treated with calcipotriene alone, and 50% of patients in the calcipotriene plus nicotinamide 1.4% group, reported Dr. Lebwohl, professor and chairman of the department of dermatology at Mount Sinai School of Medicine, New York.

The 50% clear or almost-clear rate with calcipotriene plus nicotinamide 1.4% is similar to the 48% rate of absent to very mild disease that was previously reported with a calcipotriol/betamethasone combination in a 52-week study (Dermatology 2006;213:319-26).

Thus, the calcipotriene/nicotinamide combination is an agent that will be investigated further in larger, lengthier studies as a possible steroid-sparing agent in comparative trials vs. calcipotriene-steroid combination therapy, Dr. Lebwohl said.

Topical combination therapy continues to be an active area in psoriasis research, he observed.

"It’s really a no-brainer: The combination of two ingredients is going to be superior to either one alone. It’s a very simple concept: Two is better than one," he said.

Dr. Lebwohl disclosed that he is a consultant to Dermipsor and has advisory board relationships with other pharmaceutical companies that are developing dermatologic drugs.