Background Melasma is an acquired hyperpigmentation disorder. Microneedling is an alternative treatment for melasma especially by improving penetration of pharmacological agents into the skin. Objective The main objective of this review was to systematize and analyze available evidence on the efficacy and safety of microneedling alone or associated with topical agents in reducing skin stains and improving melasma‐related quality of life in adult patients. Methods Only randomized clinical trials were included. The following databases were consulted: MEDLINE, Embase, Cochrane, and the gray literature. The Cochrane risk‐of‐bias tool for randomized trials (RoB 2.0) was used to assess risk of bias. Results The search retrieved 719 records and seven studies were included. A total of 368 participants (96.19% women) were evaluated. Two studies were split‐face. Most of the studies evaluated microneedling associated with tranexamic acid. High risk of bias was presented by most studies, especially in the safety outcome. A significant decrease was observed in the MASI, mMASI, or hemi‐MASI scores, regardless of the topical agents associated. Meta‐analysis was not possible due to the heterogeneity of the studies. Conclusion Based on the results of this review, microneedling can, in association with topical agents or isolated, be used safely in the treatment of melasma in the clinical practice, obtaining results on reduction of stain severity and improvement of patients' quality of life.
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