Laser 2015

KISSIMMEE, FLA. – Using a needle-free device to inject nodular basal cell carcinomas with intralesional 5-aminolevulinic acid before photodynamic therapy led to complete, years-long remissions and few side effects in a small case series.

“This approach represents an interesting alternative to Mohs, for sure,” Dr. Daniel Barolet said at the annual meeting of the American Society for Laser Medicine and Surgery. “The secret is in the injector nozzle, which lets you inject with multiple openings to get the best uniformity around the tumor.”

Mohs micrographic surgery remains the standard for basal cell carcinoma (BCC) in high-risk sites, and the number of Mohs surgeries has approximately doubled since 2001, said Dr. Barolet, adjunct professor of dermatology at McGill University in Montreal.

Mohs, however, can cause scarring, and BCCs recur in about 4% of patients. In contrast, photodynamic therapy (PDT) is associated with less scarring and pain, fewer complications, shorter recovery times, and lower costs, although the recurrence rate is about 14%, he noted.

Since PDT alone does not efficiently penetrate thick tumor volumes, it works best with pretreatment using agents such as aminolevulinic acid (ALA).

Using needles to inject the tumor, however, can cause pain, vascular damage, vasoconstriction, deep purpura, necrosis, and infection. “Because of this, no-needle injection is an interesting avenue for PDT,” he noted. Needle-free devices currently are used to inject insulin and to administer some vaccines. They are “virtually painless,” noninvasive, and tissue sparing, he said.

To explore the potential role for needle-free injection in ALA-PDT, Dr. Barolot used a prototype high-speed jet to deliver intralesional 5-ALA in the nodular facial BCCs of four patients. He then performed photoactivation with a red light–emitting diode, with continuous wave at 630 nm, irradiance at 50 mW/cm², and total fluence 50-100 J/cm².

Patients had no evidence of clinical or histopathologic recurrence for up to 7 years after treatment, Dr. Barolet reported. They experienced mild crusting at treated sites for up to a week after treatment, but no other adverse effects. Two patients needed a second treatment 2 months after the initial treatment to achieve complete remission. “Excellent cosmesis was obtained,” he added, pointing to before and after photos that showed no evidence of lesions several months after treatment.

Multicenter clinical trials are needed to further evaluate the modality, but the preliminary data suggest that intralesional PDT is a reasonable alternative to Mohs for BCCs in high-risk body sites, as long as lesions are few in number and do not affect large areas of the body, Dr. Barolet said.

The modality is especially well suited to “tricky” areas of the body that are difficult to treat with Mohs, he said.

“Developing a user-friendly, disposable no-needle injector will make it much easier for users,” he added. For low-risk BCCs in low-risk sites, conventional treatments such as surgical excision remain the best option, he said.

Dr. Barolet reported no funding sources for the study and said he had no relevant financial disclosures.

KISSIMMEE, FLA. – Using a needle-free device to inject nodular basal cell carcinomas with intralesional 5-aminolevulinic acid before photodynamic therapy led to complete, years-long remissions and few side effects in a small case series.

“This approach represents an interesting alternative to Mohs, for sure,” Dr. Daniel Barolet said at the annual meeting of the American Society for Laser Medicine and Surgery. “The secret is in the injector nozzle, which lets you inject with multiple openings to get the best uniformity around the tumor.”

Mohs micrographic surgery remains the standard for basal cell carcinoma (BCC) in high-risk sites, and the number of Mohs surgeries has approximately doubled since 2001, said Dr. Barolet, adjunct professor of dermatology at McGill University in Montreal.

Mohs, however, can cause scarring, and BCCs recur in about 4% of patients. In contrast, photodynamic therapy (PDT) is associated with less scarring and pain, fewer complications, shorter recovery times, and lower costs, although the recurrence rate is about 14%, he noted.

Since PDT alone does not efficiently penetrate thick tumor volumes, it works best with pretreatment using agents such as aminolevulinic acid (ALA).

Using needles to inject the tumor, however, can cause pain, vascular damage, vasoconstriction, deep purpura, necrosis, and infection. “Because of this, no-needle injection is an interesting avenue for PDT,” he noted. Needle-free devices currently are used to inject insulin and to administer some vaccines. They are “virtually painless,” noninvasive, and tissue sparing, he said.

To explore the potential role for needle-free injection in ALA-PDT, Dr. Barolot used a prototype high-speed jet to deliver intralesional 5-ALA in the nodular facial BCCs of four patients. He then performed photoactivation with a red light–emitting diode, with continuous wave at 630 nm, irradiance at 50 mW/cm², and total fluence 50-100 J/cm².

Patients had no evidence of clinical or histopathologic recurrence for up to 7 years after treatment, Dr. Barolet reported. They experienced mild crusting at treated sites for up to a week after treatment, but no other adverse effects. Two patients needed a second treatment 2 months after the initial treatment to achieve complete remission. “Excellent cosmesis was obtained,” he added, pointing to before and after photos that showed no evidence of lesions several months after treatment.

Multicenter clinical trials are needed to further evaluate the modality, but the preliminary data suggest that intralesional PDT is a reasonable alternative to Mohs for BCCs in high-risk body sites, as long as lesions are few in number and do not affect large areas of the body, Dr. Barolet said.

The modality is especially well suited to “tricky” areas of the body that are difficult to treat with Mohs, he said.

“Developing a user-friendly, disposable no-needle injector will make it much easier for users,” he added. For low-risk BCCs in low-risk sites, conventional treatments such as surgical excision remain the best option, he said.

Dr. Barolet reported no funding sources for the study and said he had no relevant financial disclosures.

KISSIMMEE, FLA. – Using a needle-free device to inject nodular basal cell carcinomas with intralesional 5-aminolevulinic acid before photodynamic therapy led to complete, years-long remissions and few side effects in a small case series.

“This approach represents an interesting alternative to Mohs, for sure,” Dr. Daniel Barolet said at the annual meeting of the American Society for Laser Medicine and Surgery. “The secret is in the injector nozzle, which lets you inject with multiple openings to get the best uniformity around the tumor.”

Mohs micrographic surgery remains the standard for basal cell carcinoma (BCC) in high-risk sites, and the number of Mohs surgeries has approximately doubled since 2001, said Dr. Barolet, adjunct professor of dermatology at McGill University in Montreal.

Mohs, however, can cause scarring, and BCCs recur in about 4% of patients. In contrast, photodynamic therapy (PDT) is associated with less scarring and pain, fewer complications, shorter recovery times, and lower costs, although the recurrence rate is about 14%, he noted.

Since PDT alone does not efficiently penetrate thick tumor volumes, it works best with pretreatment using agents such as aminolevulinic acid (ALA).

Using needles to inject the tumor, however, can cause pain, vascular damage, vasoconstriction, deep purpura, necrosis, and infection. “Because of this, no-needle injection is an interesting avenue for PDT,” he noted. Needle-free devices currently are used to inject insulin and to administer some vaccines. They are “virtually painless,” noninvasive, and tissue sparing, he said.

To explore the potential role for needle-free injection in ALA-PDT, Dr. Barolot used a prototype high-speed jet to deliver intralesional 5-ALA in the nodular facial BCCs of four patients. He then performed photoactivation with a red light–emitting diode, with continuous wave at 630 nm, irradiance at 50 mW/cm², and total fluence 50-100 J/cm².

Patients had no evidence of clinical or histopathologic recurrence for up to 7 years after treatment, Dr. Barolet reported. They experienced mild crusting at treated sites for up to a week after treatment, but no other adverse effects. Two patients needed a second treatment 2 months after the initial treatment to achieve complete remission. “Excellent cosmesis was obtained,” he added, pointing to before and after photos that showed no evidence of lesions several months after treatment.

Multicenter clinical trials are needed to further evaluate the modality, but the preliminary data suggest that intralesional PDT is a reasonable alternative to Mohs for BCCs in high-risk body sites, as long as lesions are few in number and do not affect large areas of the body, Dr. Barolet said.

The modality is especially well suited to “tricky” areas of the body that are difficult to treat with Mohs, he said.

“Developing a user-friendly, disposable no-needle injector will make it much easier for users,” he added. For low-risk BCCs in low-risk sites, conventional treatments such as surgical excision remain the best option, he said.

Dr. Barolet reported no funding sources for the study and said he had no relevant financial disclosures.

KISSIMMEE, FLA. – A perfluorodecalin-infused patch lessened reactive whitening and accelerated clearing in 65% of tattoos treated with 755-nm Q-switched lasers in a single-center, split-tattoo study.

“Most subjects showed obvious accelerated clearing on the patch side of the tattoo, and preferred the patch-treated side compared with the control side,” Dr. Brian Biesman said at the annual meeting of the American Society for Laser Medicine and Surgery. “Despite the small number of patients, the study was powered sufficiently to address our qualitative question: Was there an enhanced rate of clearance relative to control when the PFD [perfluorodecalin] patch is used?”

Amy Karon/Frontline Medical News

Passing a laser across a tattoo triggers an immediate whitening reaction that blocks light and takes about 20 minutes to resolve, said Dr. Biesman, who is clinical assistant professor at Vanderbilt University and director of the Nashville Centre for Laser and Facial Surgery. Removing tattoos with Q-switched lasers can take months to years because it involves making a single pass each month. A past study showed that topical PFD resolved whitening in seconds, allowing operators to make multiple passes in 5 minutes. but the patch seems to have additional dermoprotective properties that enable patients to tolerate higher fluence as well as multiple passes, Dr. Biesman said.

The study included 17 patients with Fitzpatrick skin types I through III who had previously untreated, dark blue or black ink tattoos measuring less than 100 cm² in area. Patients with suntans, blood-borne diseases, oral retinoid exposure in the past 12 months, or lidocaine allergies were excluded, he said. All patients underwent monthly treatments with a conventional Q-switched alexandrite laser after pretreatment with topical lidocaine. The control (uncovered) half of each tattoo received a single laser pass, while the half covered by the patch received the maximum tolerable fluence and number of passes in 5 minutes.

The PFD patch was associated with substantially faster clearance, compared with the control, in 11 of 17 patients (65%). Patients tolerated 1.5 to 1.8 times greater fluence and about four passes per session on the patch side. They also developed no serious or unexpected side effects, said Dr. Biesman.

Responses to the patch varied widely, however, ranging from no visible improvement after many sessions to more than 80% greater clearance after two sessions, compared with the control side. Larger studies would be needed to examine predictors of success, he added, noting that the composition of tattoo ink affects response, and that clinicians rarely, if ever, know which inks were used.

It also remains unclear whether faster clearing was the result of multiple passes or higher fluence. The PFD patch reduces scatter in the dermis and epidermis, which could facilitate use of higher fluence, he said.

On April 20, the Food and Drug Administration cleared the PFD patch for use as an accessory to tattoo removal with a 755-nm Q-switched alexandrite laser in Fitzpatrick skin types I through III under the agency’s 510(k) medical device regulatory process, according to Dr. Biesman.

ON Light Sciences manufactures the patch. Dr. Biesman reported receiving grant support and holding ownership interest in ON Light Sciences and also reported financial relationships with a number of other pharmaceutical and device companies.

KISSIMMEE, FLA. – A perfluorodecalin-infused patch lessened reactive whitening and accelerated clearing in 65% of tattoos treated with 755-nm Q-switched lasers in a single-center, split-tattoo study.

“Most subjects showed obvious accelerated clearing on the patch side of the tattoo, and preferred the patch-treated side compared with the control side,” Dr. Brian Biesman said at the annual meeting of the American Society for Laser Medicine and Surgery. “Despite the small number of patients, the study was powered sufficiently to address our qualitative question: Was there an enhanced rate of clearance relative to control when the PFD [perfluorodecalin] patch is used?”

Amy Karon/Frontline Medical News

Passing a laser across a tattoo triggers an immediate whitening reaction that blocks light and takes about 20 minutes to resolve, said Dr. Biesman, who is clinical assistant professor at Vanderbilt University and director of the Nashville Centre for Laser and Facial Surgery. Removing tattoos with Q-switched lasers can take months to years because it involves making a single pass each month. A past study showed that topical PFD resolved whitening in seconds, allowing operators to make multiple passes in 5 minutes. but the patch seems to have additional dermoprotective properties that enable patients to tolerate higher fluence as well as multiple passes, Dr. Biesman said.

The study included 17 patients with Fitzpatrick skin types I through III who had previously untreated, dark blue or black ink tattoos measuring less than 100 cm² in area. Patients with suntans, blood-borne diseases, oral retinoid exposure in the past 12 months, or lidocaine allergies were excluded, he said. All patients underwent monthly treatments with a conventional Q-switched alexandrite laser after pretreatment with topical lidocaine. The control (uncovered) half of each tattoo received a single laser pass, while the half covered by the patch received the maximum tolerable fluence and number of passes in 5 minutes.

The PFD patch was associated with substantially faster clearance, compared with the control, in 11 of 17 patients (65%). Patients tolerated 1.5 to 1.8 times greater fluence and about four passes per session on the patch side. They also developed no serious or unexpected side effects, said Dr. Biesman.

Responses to the patch varied widely, however, ranging from no visible improvement after many sessions to more than 80% greater clearance after two sessions, compared with the control side. Larger studies would be needed to examine predictors of success, he added, noting that the composition of tattoo ink affects response, and that clinicians rarely, if ever, know which inks were used.

It also remains unclear whether faster clearing was the result of multiple passes or higher fluence. The PFD patch reduces scatter in the dermis and epidermis, which could facilitate use of higher fluence, he said.

On April 20, the Food and Drug Administration cleared the PFD patch for use as an accessory to tattoo removal with a 755-nm Q-switched alexandrite laser in Fitzpatrick skin types I through III under the agency’s 510(k) medical device regulatory process, according to Dr. Biesman.

ON Light Sciences manufactures the patch. Dr. Biesman reported receiving grant support and holding ownership interest in ON Light Sciences and also reported financial relationships with a number of other pharmaceutical and device companies.

KISSIMMEE, FLA. – A perfluorodecalin-infused patch lessened reactive whitening and accelerated clearing in 65% of tattoos treated with 755-nm Q-switched lasers in a single-center, split-tattoo study.

“Most subjects showed obvious accelerated clearing on the patch side of the tattoo, and preferred the patch-treated side compared with the control side,” Dr. Brian Biesman said at the annual meeting of the American Society for Laser Medicine and Surgery. “Despite the small number of patients, the study was powered sufficiently to address our qualitative question: Was there an enhanced rate of clearance relative to control when the PFD [perfluorodecalin] patch is used?”

Amy Karon/Frontline Medical News

Passing a laser across a tattoo triggers an immediate whitening reaction that blocks light and takes about 20 minutes to resolve, said Dr. Biesman, who is clinical assistant professor at Vanderbilt University and director of the Nashville Centre for Laser and Facial Surgery. Removing tattoos with Q-switched lasers can take months to years because it involves making a single pass each month. A past study showed that topical PFD resolved whitening in seconds, allowing operators to make multiple passes in 5 minutes. but the patch seems to have additional dermoprotective properties that enable patients to tolerate higher fluence as well as multiple passes, Dr. Biesman said.

The study included 17 patients with Fitzpatrick skin types I through III who had previously untreated, dark blue or black ink tattoos measuring less than 100 cm² in area. Patients with suntans, blood-borne diseases, oral retinoid exposure in the past 12 months, or lidocaine allergies were excluded, he said. All patients underwent monthly treatments with a conventional Q-switched alexandrite laser after pretreatment with topical lidocaine. The control (uncovered) half of each tattoo received a single laser pass, while the half covered by the patch received the maximum tolerable fluence and number of passes in 5 minutes.

The PFD patch was associated with substantially faster clearance, compared with the control, in 11 of 17 patients (65%). Patients tolerated 1.5 to 1.8 times greater fluence and about four passes per session on the patch side. They also developed no serious or unexpected side effects, said Dr. Biesman.

Responses to the patch varied widely, however, ranging from no visible improvement after many sessions to more than 80% greater clearance after two sessions, compared with the control side. Larger studies would be needed to examine predictors of success, he added, noting that the composition of tattoo ink affects response, and that clinicians rarely, if ever, know which inks were used.

It also remains unclear whether faster clearing was the result of multiple passes or higher fluence. The PFD patch reduces scatter in the dermis and epidermis, which could facilitate use of higher fluence, he said.

On April 20, the Food and Drug Administration cleared the PFD patch for use as an accessory to tattoo removal with a 755-nm Q-switched alexandrite laser in Fitzpatrick skin types I through III under the agency’s 510(k) medical device regulatory process, according to Dr. Biesman.

ON Light Sciences manufactures the patch. Dr. Biesman reported receiving grant support and holding ownership interest in ON Light Sciences and also reported financial relationships with a number of other pharmaceutical and device companies.