The efficacy and safety of micro-needling combined with tacrolimus versus tacrolimus monotherapy for vitiligo treatment: a systematic review and meta-analysis.

Abstract

Tacrolimus is a topical immunomodulator that has been used successfully in treating vitiligo; however, recent studies suggested that combining tacrolimus with micro-needling can increase its efficacy. This systematic review aimed to assess the efficacy and safety of micro-needling combined with tacrolimus to treat localized and stable nonsegmental vitiligo. We searched Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL). The risk ratio (RR) was used to represent dichotomous outcomes, whereas the odds ratio (OR) was used for adverse events. Three randomized control trials (RCTs) (n=148 participants) were deemed eligible. The pooled effect estimate showed a statistically significant higher re-pigmentation rate in all assessed body areas in favor of treatment with micro-needling combined with tacrolimus (RR=2.02, 95% CI: 1.51-2.70). Nonetheless, no significant difference was found between micro-needling combined with tacrolimus and tacrolimus monotherapy in terms of 5-grade re-pigmentation scale (RR=0.93, 95% CI: 0.53-1.62), histopathological assessment (RR=0.90, 95% CI 0.47-1.75), and adverse events (OR: 1.72, 95% CI: 0.10-29.36). The number of included studies is low, with a relatively low sample size. Micro-needling combined with tacrolimus showed a clinically and statistically substantial improvement in the re-pigmentation of vitiligo sites with acceptable tolerability and safety profile.