Evaluation of a transparent perfluorodecalin-infused patch as an adjunct to laser-assisted tattoo removal: A pivotal trial.

Abstract

Laser-assisted treatment of tattoos is well recognized to produce opaque epidermal whitening that prevents multiple sequential passes during a single treatment session. The amount of epidermal whitening produced in association with the procedure can be minimized by topical application of perfluorodecalin (PFD), which is an optical clearing agent. This pivotal trial assessed the ability of a transparent PFD-infused patch used in conjunction with a Q-switched nanosecond laser in the treatment of tattoos to permit multiple laser passes during a single 5 minute treatment session in comparison to the number of passes that could be completed using conventional treatment of the tattoo with the laser alone. Thirty subjects (mean age 37 years; 14 males) with predominantly dark blue or black tattoos were enrolled in a split-tattoo trial. One half of each tattoo was treated conventionally, whereas the other half was treated through the PFD patch. Treatments were performed using a nanosecond Q-switched 755-nm Alexandrite laser. The number of treatments performed in a 5-minute time period was quantified for each side of the tattoo (primary effectiveness outcome). Patient-reported pain scores and adverse events (AEs) were also evaluated. Significantly more laser passes could be made on average using the PFD patch compared with treatment using the laser alone (3.7 passes vs. 1.4 passes; P < 0.001). AEs were limited to those expected during laser removal of tattoos. The proportions of subjects with transient edema and erythema were lower in the PFD patch treatment group (36.7% vs. 63.3% and 33.3% vs. 70.0%, respectively); all AEs were transient and resolved quickly. No patient in either group exhibited dyschromia (hypo- or hyperpigmentation) in the treatment area at the 1-month post treatment visit. Additionally, when surveyed at the 1-month follow-up visit, all subjects (30/30) preferred to continue laser-assisted tattoo removal with the PFD patch. An average of 3.7 laser passes were made in a defined 5-minute treatment session when using the transparent PFD-infused patch, which is significantly more than was possible with the laser alone (average of 1.4 passes). Use of the PFD patch was associated with improved tolerability compared with conventional treatment, with subjects experiencing fewer and less severe AEs related to epidermal injury. Lasers Surg. Med. 49:335-340, 2017. © 2017 Wiley Periodicals, Inc.