Vitiligo treatment with Monochromatic Excimer Light and Tacrolimus: results of an open randomised controlled study.

Background data: Narrow band UVB is an effective and safe option for the treatment of vitiligo. However, a complete and long-lasting repigmention of vitiligo patches is difficult to achieve. Combined treatments with novel sources of phototherapy and topical agents represent possible new strategies. Objective: The purpose of this study was to compare the efficacy of combined tacrolimus and 308-nm excimer light (MEL) vs 308-nm MEL monotherapy in treating vitiligo in a controlled study. Methods: Fifty-three patients affected by vitiligo were enrolled in this open prospective study. Patients were divided into three groups: Group I included 20 patients treated with MEL 308nm twice weekly and oral vitamin E; Group II included 20 patients treated with MEL 308nm twice weekly combined with 0.1% tacrolimus once a day and oral vitamin E; and Group III included 13 patients treated only with oral vitamin E. Efficacy was assessed at the end of 12 weeks based on the percentage of repigmentation. Results: Fifty-two patients completed 12 weeks of treatment. Group I (MEL + vitamin E) showed a moderate repigmentation in 35% of patients, good repigmentation in 30%, excellent repigmentation in 25%, and poor repigmentation in 10%; Group II (MEL + tacrolimus 0.1% + vitamin E) presented moderate repigmentation in 25% of patients, good repigmentation in 40%, excellent repigmentation in 30%, and poor repigmentation in 5%; Group III (vitamin E) showed moderate repigmentation in 16% and 84% did not show signs of repigmentation. Conclusions: Our results demonstrate that the combination treatment of 0.1% tacrolimus ointment plus 308-nm MEL and 308-nm MEL monotherapy are effective, safe, and well tolerated for the treatment of vitiligo compared to treatment with vitamin E. Furthermore, this study suggests that an association with topical immunomodulators could enhance the clinical response in vitiligo, especially in more resistant anatomical sites.