A Randomized, Controlled, Split-Face, Double-Blind Study Comparing Topical Malassezin to Hydroquinone 4% for Melasma

Previous studies have documented the capacity of malassezin to brighten the skin. It represents a novel agent for the treatment of hyperpigmentation.

To compare the efficacy and safety of a topical 0.75% malassezin formulation to 4% hydroquinone, the gold standard for treating melasma.

A randomized, controlled, split-face, double-blind study was conducted in 20 adult female subjects with symmetrical mild-to-moderate melasma. Subjects were randomized 1:1 to determine the allotted side of the face treated twice per day with malassezin or hydroquinone for 12 weeks. Treatment efficacy was evaluated by measuring brightening effects, global improvement, split-face Melasma Area Severity Index (hemi-MASI) scores, colorimetry measurements, and photography.

Twenty subjects completed the study. Compared to baseline, both malassezin and hydroquinone-treated facial areas showed significant efficacy at 12 weeks in brightening (1.85 and 1.95, P=0.027 and 0.008); global improvement (2.2 and 2.3, P=0.004 and 0.001); and hemi-MASI reduction (2.49 and 2.33; P<0.001 and P<0.001), respectively. However, there were no statistically significant differences when comparing the malassezin-treated side to the hydroquinone-treated side at each visit. Side effects in both groups were mild throughout the study.

These findings suggest that malassezin shows comparable efficacy to the gold standard, hydroquinone. Our results further support malassezin as a promising new treatment for patients with melasma.  .