Actinic Keratosis

ORLANDO — Daily application of 3.75% imiquimod cream with a 2-week dosing cycle was well tolerated and effective for treating actinic keratoses in adults, based on data from two studies.

In current treatment regimens, some patients use a 5% concentration imiquimod (Aldara, Graceway) cream twice a week over a treatment period as long as 16 weeks, but a lower dose may allow a shorter treatment period, said Dr. Neil Swanson of Oregon Health and Science University, Portland.

Dr. Swanson and his colleagues randomized 160 patients to 3.75% imiquimod cream, 160 patients to 2.5% imiquimod cream, and 159 patients to a placebo cream. The patients, aged 18 years and older, had 5-20 clinically diagnosed actinic keratoses (AKs) on the face or balding scalp. The study results were presented in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.

Both the 3.75% and 2.5% creams were significantly more effective than placebo at fully clearing AKs after 2 weeks of daily use. Overall, 36% of the 3.75% group and 31% of the 2.5% group achieved complete clearance, vs. 6% of the placebo group.

The 3.75% cream, however, was significantly better than the 2.5% cream for partial clearance and lesion reduction. Approximately 60% of the 3.75% group achieved partial clearance (defined as at least 75%), compared with 48% of the 2.5% group and 23% of the placebo group.

Both concentrations of imiquimod were well tolerated, and most local skin reactions were mild to moderate. Local skin reactions occurred in 1% of the placebo group, 21% of the 2.5% group, and 34% of the 3.75% group. The most common local skin reactions in both groups were erythema, scabbing or crusting, and erosion or ulceration.

"Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks in treating a smaller area of fewer lesions," the researchers noted. By comparison, the median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group. The average lesion count at baseline was 11 in all three groups.

Patients applied the treatment cream or placebo daily to the treatment areas for approximately 8 hours or overnight and then removed it. The study included two 2-week cycles separated by a 2-week no-treatment period.

In a companion study also presented as a poster at the meeting, there was no significant improvement in effectiveness with either imiquimod 2.5% or 3.75% cream for treating AKs when used daily for two 3-week cycles separated by a 3-week no-treatment period. The study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream.

Both imiquimod creams were adequately tolerated and significantly more effective than placebo, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and colleagues.

When both studies were evaluated together, though, "efficacy was better with imiquimod 3.75% than with 2.5%. Extending the cycle duration from 2 weeks to 3 weeks did not further increase efficacy," Dr. Hanke and his associates wrote.

Both studies were funded by Graceway Pharmaceuticals. Both Dr. Swanson and Dr. Hanke have served as investigators and consultants for Graceway. Coauthors on both studies include other investigators, consultants, and employees of Graceway.

ORLANDO — Daily application of 3.75% imiquimod cream with a 2-week dosing cycle was well tolerated and effective for treating actinic keratoses in adults, based on data from two studies.

In current treatment regimens, some patients use a 5% concentration imiquimod (Aldara, Graceway) cream twice a week over a treatment period as long as 16 weeks, but a lower dose may allow a shorter treatment period, said Dr. Neil Swanson of Oregon Health and Science University, Portland.

Dr. Swanson and his colleagues randomized 160 patients to 3.75% imiquimod cream, 160 patients to 2.5% imiquimod cream, and 159 patients to a placebo cream. The patients, aged 18 years and older, had 5-20 clinically diagnosed actinic keratoses (AKs) on the face or balding scalp. The study results were presented in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.

Both the 3.75% and 2.5% creams were significantly more effective than placebo at fully clearing AKs after 2 weeks of daily use. Overall, 36% of the 3.75% group and 31% of the 2.5% group achieved complete clearance, vs. 6% of the placebo group.

The 3.75% cream, however, was significantly better than the 2.5% cream for partial clearance and lesion reduction. Approximately 60% of the 3.75% group achieved partial clearance (defined as at least 75%), compared with 48% of the 2.5% group and 23% of the placebo group.

Both concentrations of imiquimod were well tolerated, and most local skin reactions were mild to moderate. Local skin reactions occurred in 1% of the placebo group, 21% of the 2.5% group, and 34% of the 3.75% group. The most common local skin reactions in both groups were erythema, scabbing or crusting, and erosion or ulceration.

"Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks in treating a smaller area of fewer lesions," the researchers noted. By comparison, the median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group. The average lesion count at baseline was 11 in all three groups.

Patients applied the treatment cream or placebo daily to the treatment areas for approximately 8 hours or overnight and then removed it. The study included two 2-week cycles separated by a 2-week no-treatment period.

In a companion study also presented as a poster at the meeting, there was no significant improvement in effectiveness with either imiquimod 2.5% or 3.75% cream for treating AKs when used daily for two 3-week cycles separated by a 3-week no-treatment period. The study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream.

Both imiquimod creams were adequately tolerated and significantly more effective than placebo, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and colleagues.

When both studies were evaluated together, though, "efficacy was better with imiquimod 3.75% than with 2.5%. Extending the cycle duration from 2 weeks to 3 weeks did not further increase efficacy," Dr. Hanke and his associates wrote.

Both studies were funded by Graceway Pharmaceuticals. Both Dr. Swanson and Dr. Hanke have served as investigators and consultants for Graceway. Coauthors on both studies include other investigators, consultants, and employees of Graceway.

ORLANDO — Daily application of 3.75% imiquimod cream with a 2-week dosing cycle was well tolerated and effective for treating actinic keratoses in adults, based on data from two studies.

In current treatment regimens, some patients use a 5% concentration imiquimod (Aldara, Graceway) cream twice a week over a treatment period as long as 16 weeks, but a lower dose may allow a shorter treatment period, said Dr. Neil Swanson of Oregon Health and Science University, Portland.

Dr. Swanson and his colleagues randomized 160 patients to 3.75% imiquimod cream, 160 patients to 2.5% imiquimod cream, and 159 patients to a placebo cream. The patients, aged 18 years and older, had 5-20 clinically diagnosed actinic keratoses (AKs) on the face or balding scalp. The study results were presented in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.

Both the 3.75% and 2.5% creams were significantly more effective than placebo at fully clearing AKs after 2 weeks of daily use. Overall, 36% of the 3.75% group and 31% of the 2.5% group achieved complete clearance, vs. 6% of the placebo group.

The 3.75% cream, however, was significantly better than the 2.5% cream for partial clearance and lesion reduction. Approximately 60% of the 3.75% group achieved partial clearance (defined as at least 75%), compared with 48% of the 2.5% group and 23% of the placebo group.

Both concentrations of imiquimod were well tolerated, and most local skin reactions were mild to moderate. Local skin reactions occurred in 1% of the placebo group, 21% of the 2.5% group, and 34% of the 3.75% group. The most common local skin reactions in both groups were erythema, scabbing or crusting, and erosion or ulceration.

"Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks in treating a smaller area of fewer lesions," the researchers noted. By comparison, the median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group. The average lesion count at baseline was 11 in all three groups.

Patients applied the treatment cream or placebo daily to the treatment areas for approximately 8 hours or overnight and then removed it. The study included two 2-week cycles separated by a 2-week no-treatment period.

In a companion study also presented as a poster at the meeting, there was no significant improvement in effectiveness with either imiquimod 2.5% or 3.75% cream for treating AKs when used daily for two 3-week cycles separated by a 3-week no-treatment period. The study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream.

Both imiquimod creams were adequately tolerated and significantly more effective than placebo, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and colleagues.

When both studies were evaluated together, though, "efficacy was better with imiquimod 3.75% than with 2.5%. Extending the cycle duration from 2 weeks to 3 weeks did not further increase efficacy," Dr. Hanke and his associates wrote.

Both studies were funded by Graceway Pharmaceuticals. Both Dr. Swanson and Dr. Hanke have served as investigators and consultants for Graceway. Coauthors on both studies include other investigators, consultants, and employees of Graceway.

MONTREAL — Actinic keratoses are dynamic lesions and their expression varies over time, based on the results of an 11-month study of the natural course of the lesions in people with extensive actinic damage.

"At any one time, less than half of the lesions are evident clinically," said Dr. Craig Elmets, who reported his findings at the annual meeting of the Society for Investigative Dermatology.

The pattern of regression and recurrence of actinic keratoses (AK) has implications for the treatment of the lesions, said Dr. Elmets, professor and chair of the department of dermatology and director of the Skin Disease Research Center at the University of Alabama, Birmingham.

"If one is going to treat individual lesions, then they need to be treated aggressively because at any one time only a minority of the [visible] AKs are present," he said. "In patients with extensive actinic damage, peel treatment may be a very good approach to treating these lesions."

Dr. Elmets did not disclose any conflicts of interest in regard to this study, but he serves on the advisory boards of several pharmaceutical companies.

The study followed AK lesions for 11 months in 26 individuals with extensive actinic damage.

At baseline, the subjects had 10–40 actinic lesions and at least one prior histological diagnosis of an AK or a nonmelanoma skin cancer.

The subjects' AKs were mapped at baseline and again at 3, 6, 9, and 11 months.

The lesions also were biopsied at baseline and the end of the study. "If a lesion that had been selected for biopsy was no longer present clinically, the site where it had been was still biopsied," Dr. Elmets explained.

At baseline, there were a total of 610 AKs in the study group (mean 23.5 per individual). At the end of the study, this number was not significantly different despite the development of 973 new lesions over the 11-month period.

About 40% of the lesions present at baseline had regressed by month 11, and nearly 200 of the lesions that were present at baseline regressed and then recurred, he said. "A total of 51 of the lesions regressed twice."

Using a histologic grading scheme that was based on a cervical dysplasia model, Dr. Elmets noted little progression in the severity of lesions in terms of proliferation, atypia, or both features. "The histologic appearance seems to accurately correlate with the clinical appearance, and over the course of 11 months there was little evidence of histologic progression."

AKs have been thought to be precursors to squamous cell carcinomas in some cases.

The presence of AKs is strongly predictive of individuals who are at increased risk for basal cell and squamous cell carcinomas, noted Dr. Elmets.

The pattern of regression and recurrence of actinic keratoses may have implications for the treatment of the lesions. Courtesy Dr. Roger I. Ceilley

MONTREAL — Actinic keratoses are dynamic lesions and their expression varies over time, based on the results of an 11-month study of the natural course of the lesions in people with extensive actinic damage.

"At any one time, less than half of the lesions are evident clinically," said Dr. Craig Elmets, who reported his findings at the annual meeting of the Society for Investigative Dermatology.

The pattern of regression and recurrence of actinic keratoses (AK) has implications for the treatment of the lesions, said Dr. Elmets, professor and chair of the department of dermatology and director of the Skin Disease Research Center at the University of Alabama, Birmingham.

"If one is going to treat individual lesions, then they need to be treated aggressively because at any one time only a minority of the [visible] AKs are present," he said. "In patients with extensive actinic damage, peel treatment may be a very good approach to treating these lesions."

Dr. Elmets did not disclose any conflicts of interest in regard to this study, but he serves on the advisory boards of several pharmaceutical companies.

The study followed AK lesions for 11 months in 26 individuals with extensive actinic damage.

At baseline, the subjects had 10–40 actinic lesions and at least one prior histological diagnosis of an AK or a nonmelanoma skin cancer.

The subjects' AKs were mapped at baseline and again at 3, 6, 9, and 11 months.

The lesions also were biopsied at baseline and the end of the study. "If a lesion that had been selected for biopsy was no longer present clinically, the site where it had been was still biopsied," Dr. Elmets explained.

At baseline, there were a total of 610 AKs in the study group (mean 23.5 per individual). At the end of the study, this number was not significantly different despite the development of 973 new lesions over the 11-month period.

About 40% of the lesions present at baseline had regressed by month 11, and nearly 200 of the lesions that were present at baseline regressed and then recurred, he said. "A total of 51 of the lesions regressed twice."

Using a histologic grading scheme that was based on a cervical dysplasia model, Dr. Elmets noted little progression in the severity of lesions in terms of proliferation, atypia, or both features. "The histologic appearance seems to accurately correlate with the clinical appearance, and over the course of 11 months there was little evidence of histologic progression."

AKs have been thought to be precursors to squamous cell carcinomas in some cases.

The presence of AKs is strongly predictive of individuals who are at increased risk for basal cell and squamous cell carcinomas, noted Dr. Elmets.

The pattern of regression and recurrence of actinic keratoses may have implications for the treatment of the lesions. Courtesy Dr. Roger I. Ceilley

MONTREAL — Actinic keratoses are dynamic lesions and their expression varies over time, based on the results of an 11-month study of the natural course of the lesions in people with extensive actinic damage.

"At any one time, less than half of the lesions are evident clinically," said Dr. Craig Elmets, who reported his findings at the annual meeting of the Society for Investigative Dermatology.

The pattern of regression and recurrence of actinic keratoses (AK) has implications for the treatment of the lesions, said Dr. Elmets, professor and chair of the department of dermatology and director of the Skin Disease Research Center at the University of Alabama, Birmingham.

"If one is going to treat individual lesions, then they need to be treated aggressively because at any one time only a minority of the [visible] AKs are present," he said. "In patients with extensive actinic damage, peel treatment may be a very good approach to treating these lesions."

Dr. Elmets did not disclose any conflicts of interest in regard to this study, but he serves on the advisory boards of several pharmaceutical companies.

The study followed AK lesions for 11 months in 26 individuals with extensive actinic damage.

At baseline, the subjects had 10–40 actinic lesions and at least one prior histological diagnosis of an AK or a nonmelanoma skin cancer.

The subjects' AKs were mapped at baseline and again at 3, 6, 9, and 11 months.

The lesions also were biopsied at baseline and the end of the study. "If a lesion that had been selected for biopsy was no longer present clinically, the site where it had been was still biopsied," Dr. Elmets explained.

At baseline, there were a total of 610 AKs in the study group (mean 23.5 per individual). At the end of the study, this number was not significantly different despite the development of 973 new lesions over the 11-month period.

About 40% of the lesions present at baseline had regressed by month 11, and nearly 200 of the lesions that were present at baseline regressed and then recurred, he said. "A total of 51 of the lesions regressed twice."

Using a histologic grading scheme that was based on a cervical dysplasia model, Dr. Elmets noted little progression in the severity of lesions in terms of proliferation, atypia, or both features. "The histologic appearance seems to accurately correlate with the clinical appearance, and over the course of 11 months there was little evidence of histologic progression."

AKs have been thought to be precursors to squamous cell carcinomas in some cases.

The presence of AKs is strongly predictive of individuals who are at increased risk for basal cell and squamous cell carcinomas, noted Dr. Elmets.

The pattern of regression and recurrence of actinic keratoses may have implications for the treatment of the lesions. Courtesy Dr. Roger I. Ceilley

CHICAGO — Topical therapy for 2 or 3 days with the investigational agent ingenol mebutate, also known as PEP005, provides substantial clearance of actinic keratosis lesions, according to findings from two phase II randomized studies.

"A comparison of efficacy outcomes with those of studies of diclofenac, 5-FU [fluorouracil], and imiquimod shows at least equivalent clearance of lesions over a much shorter period," Dr. Lawrence Anderson, one of the current study's lead investigators, reported at the American Academy of Dermatology's Academy 2008 meeting.

Ingenol mebutate gel has the potential to enhance compliance not only by its shorter course of therapy, but also by the truncated period of irritation in patients with actinic keratosis (AK), the investigators suggested.

PEP005 is a new class of compound derived from the sap of Euphorbia peplus, a readily available plant that has been used in Australia for centuries as a traditional treatment for skin conditions. The two current studies were sponsored by Peplin Ltd. of Brisbane, Australia, which is developing PEP005.

Dr. Anderson, who is in private dermatology practice in Tyler, Texas, and his associates randomized 222 patients with 4- 8 visible AK lesions on the arm, shoulder, chest, back, or scalp, to one of four treatment groups. The primary end point was partial clearance, defined as the proportion of patients at day 57 with 75% reduction in the number of AK lesions identified at baseline.

Treatment with PEP005 gel once daily for 2 or 3 days produced significantly greater lesion clearance in a dose-dependent manner by all measures and at all dosing regimens, compared with a control vehicle applied once daily for 3 days.

The partial clearance rate was 22% for vehicle, 56% for ingenol mebutate gel 0.025% for 3 days, 62% for ingenol mebutate gel 0.05% for 2 days, and 75.4% for ingenol mebutate 0.05% for 3 days.

The proportion of patients at day 57 with complete clearance, defined as no clinically visible AK lesions, was 12%, 40%, 44%, and 54.4%, respectively.

All three active treatments were well tolerated, according to the investigators, one of whom was a Peplin employee. The most common lesion-site reactions on day 57 were erythema, experienced by 34% of 162 actively treated patients; flaking or scaling (29%); and crusting (9%).

Because AK lesions on the trunk and extremities historically are more difficult to treat than scalp lesions, the investigators performed an ad hoc analysis to compare outcomes in patients with scalp and nonscalp lesions, Dr. Michael Freeman of the Skin Centre, Gold Coast, Australia, and his associates said in a separate poster.

Overall, scalp treatment areas had a higher complete clearance rate than nonscalp treatment areas (57% vs. 42.4%), although the gel was better tolerated when applied to nonscalp areas, regardless of concentration or dosing schedule, the investigators wrote.

The maximum tolerated dose (MTD) for face or face and scalp AK was determined to be once-daily ingenol mebutate gel 0.025% for 2 days, according to a second study that evaluated six formulation strengths ranging from 0.0025% to 0.025% in 86 patients with lesions limited to the face or face and scalp.

At the MTD, 26 of 36 patients (72%) achieved partial clearance and 14 of the 36 (39%) achieved complete clearance.

Ingenol mebutate gel was well tolerated across all strengths, with erythema the most common lesion site reaction. Three patients experienced four serious adverse events, none considered treatment related, according to the investigators, one of whom was also a Peplin employee.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Topical therapy for 2 or 3 days with the investigational agent ingenol mebutate, also known as PEP005, provides substantial clearance of actinic keratosis lesions, according to findings from two phase II randomized studies.

"A comparison of efficacy outcomes with those of studies of diclofenac, 5-FU [fluorouracil], and imiquimod shows at least equivalent clearance of lesions over a much shorter period," Dr. Lawrence Anderson, one of the current study's lead investigators, reported at the American Academy of Dermatology's Academy 2008 meeting.

Ingenol mebutate gel has the potential to enhance compliance not only by its shorter course of therapy, but also by the truncated period of irritation in patients with actinic keratosis (AK), the investigators suggested.

PEP005 is a new class of compound derived from the sap of Euphorbia peplus, a readily available plant that has been used in Australia for centuries as a traditional treatment for skin conditions. The two current studies were sponsored by Peplin Ltd. of Brisbane, Australia, which is developing PEP005.

Dr. Anderson, who is in private dermatology practice in Tyler, Texas, and his associates randomized 222 patients with 4- 8 visible AK lesions on the arm, shoulder, chest, back, or scalp, to one of four treatment groups. The primary end point was partial clearance, defined as the proportion of patients at day 57 with 75% reduction in the number of AK lesions identified at baseline.

Treatment with PEP005 gel once daily for 2 or 3 days produced significantly greater lesion clearance in a dose-dependent manner by all measures and at all dosing regimens, compared with a control vehicle applied once daily for 3 days.

The partial clearance rate was 22% for vehicle, 56% for ingenol mebutate gel 0.025% for 3 days, 62% for ingenol mebutate gel 0.05% for 2 days, and 75.4% for ingenol mebutate 0.05% for 3 days.

The proportion of patients at day 57 with complete clearance, defined as no clinically visible AK lesions, was 12%, 40%, 44%, and 54.4%, respectively.

All three active treatments were well tolerated, according to the investigators, one of whom was a Peplin employee. The most common lesion-site reactions on day 57 were erythema, experienced by 34% of 162 actively treated patients; flaking or scaling (29%); and crusting (9%).

Because AK lesions on the trunk and extremities historically are more difficult to treat than scalp lesions, the investigators performed an ad hoc analysis to compare outcomes in patients with scalp and nonscalp lesions, Dr. Michael Freeman of the Skin Centre, Gold Coast, Australia, and his associates said in a separate poster.

Overall, scalp treatment areas had a higher complete clearance rate than nonscalp treatment areas (57% vs. 42.4%), although the gel was better tolerated when applied to nonscalp areas, regardless of concentration or dosing schedule, the investigators wrote.

The maximum tolerated dose (MTD) for face or face and scalp AK was determined to be once-daily ingenol mebutate gel 0.025% for 2 days, according to a second study that evaluated six formulation strengths ranging from 0.0025% to 0.025% in 86 patients with lesions limited to the face or face and scalp.

At the MTD, 26 of 36 patients (72%) achieved partial clearance and 14 of the 36 (39%) achieved complete clearance.

Ingenol mebutate gel was well tolerated across all strengths, with erythema the most common lesion site reaction. Three patients experienced four serious adverse events, none considered treatment related, according to the investigators, one of whom was also a Peplin employee.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Topical therapy for 2 or 3 days with the investigational agent ingenol mebutate, also known as PEP005, provides substantial clearance of actinic keratosis lesions, according to findings from two phase II randomized studies.

"A comparison of efficacy outcomes with those of studies of diclofenac, 5-FU [fluorouracil], and imiquimod shows at least equivalent clearance of lesions over a much shorter period," Dr. Lawrence Anderson, one of the current study's lead investigators, reported at the American Academy of Dermatology's Academy 2008 meeting.

Ingenol mebutate gel has the potential to enhance compliance not only by its shorter course of therapy, but also by the truncated period of irritation in patients with actinic keratosis (AK), the investigators suggested.

PEP005 is a new class of compound derived from the sap of Euphorbia peplus, a readily available plant that has been used in Australia for centuries as a traditional treatment for skin conditions. The two current studies were sponsored by Peplin Ltd. of Brisbane, Australia, which is developing PEP005.

Dr. Anderson, who is in private dermatology practice in Tyler, Texas, and his associates randomized 222 patients with 4- 8 visible AK lesions on the arm, shoulder, chest, back, or scalp, to one of four treatment groups. The primary end point was partial clearance, defined as the proportion of patients at day 57 with 75% reduction in the number of AK lesions identified at baseline.

Treatment with PEP005 gel once daily for 2 or 3 days produced significantly greater lesion clearance in a dose-dependent manner by all measures and at all dosing regimens, compared with a control vehicle applied once daily for 3 days.

The partial clearance rate was 22% for vehicle, 56% for ingenol mebutate gel 0.025% for 3 days, 62% for ingenol mebutate gel 0.05% for 2 days, and 75.4% for ingenol mebutate 0.05% for 3 days.

The proportion of patients at day 57 with complete clearance, defined as no clinically visible AK lesions, was 12%, 40%, 44%, and 54.4%, respectively.

All three active treatments were well tolerated, according to the investigators, one of whom was a Peplin employee. The most common lesion-site reactions on day 57 were erythema, experienced by 34% of 162 actively treated patients; flaking or scaling (29%); and crusting (9%).

Because AK lesions on the trunk and extremities historically are more difficult to treat than scalp lesions, the investigators performed an ad hoc analysis to compare outcomes in patients with scalp and nonscalp lesions, Dr. Michael Freeman of the Skin Centre, Gold Coast, Australia, and his associates said in a separate poster.

Overall, scalp treatment areas had a higher complete clearance rate than nonscalp treatment areas (57% vs. 42.4%), although the gel was better tolerated when applied to nonscalp areas, regardless of concentration or dosing schedule, the investigators wrote.

The maximum tolerated dose (MTD) for face or face and scalp AK was determined to be once-daily ingenol mebutate gel 0.025% for 2 days, according to a second study that evaluated six formulation strengths ranging from 0.0025% to 0.025% in 86 patients with lesions limited to the face or face and scalp.

At the MTD, 26 of 36 patients (72%) achieved partial clearance and 14 of the 36 (39%) achieved complete clearance.

Ingenol mebutate gel was well tolerated across all strengths, with erythema the most common lesion site reaction. Three patients experienced four serious adverse events, none considered treatment related, according to the investigators, one of whom was also a Peplin employee.

ELSEVIER GLOBAL MEDICAL NEWS