Treatment of port wine stains using Pulsed Dye Laser, Erbium YAG Laser, and topical rapamycin (sirolimus)—A randomized controlled trial

Background and Objective Pulsed Dye Laser (PDL) is currently the gold standard treatment for port wine stains (PWS), although the degree of lesion blanching is variable and often unpredictable. This appears to be due to reformation and reperfusion of blood vessels. Rapamycin has shown potential as an antiangiogenic agent and may prevent the revascularization after PDL treatment. The objective of this study was to evaluate the efficacy of adjuvant use of (commercially available) topical rapamycin after PDL treatment in patients with PWS. Materials and Methods We conducted a prospective, intra‐patient, randomized controlled trial. Four treatment areas of 1 cm2 were created in each PWS. PDL‐only treatment was compared to the following three treatments: PDL + rapamycin, PDL + Erbium YAG laser ablation of the stratum corneum + rapamycin, and rapamycin monotherapy. We also compared PDL + Erbium YAG + rapamycin with PDL + rapamycin. The primary endpoint was the percentage clearance assessed colorimetrically at 6 months follow‐up. Secondary outcomes were photographic evaluation by an expert panel, patient satisfaction, treatment related pain, and safety. Results Fourteen patients completed the treatment protocol. The highest percentage clearance was achieved with PDL‐only treatment (mean [SD] 16% [34]), but there were no statistically significant differences between treatments. The best photographic evaluation and highest patient satisfaction were also achieved with PDL‐only treatment, but only the difference between PDL‐only and rapamycin monotherapy was statistically significant. The treatment related pain was well tolerated. Application‐site pruritus was a frequent occurring adverse event. Allergic contact dermatitis to rapamycin occurred in one patient. There were no serious adverse events. Conclusion Topical application of the commercially available solution of rapamycin (Rapamune® 0.1%) as an adjuvant to PDL treatment does not appear to improve PWS blanching. Lasers Surg. Med. 49:104–109, 2017. © 2016 Wiley Periodicals, Inc.