KISSIMMEE, FLA. (FRONTLINE MEDICAL NEWS)– 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?”
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.