Malassezin is a natural indole compound produced by the fungus Malassezia furfur which causes Tinea Versicolor characterized by patches of hypo and/or hyperpigmentation. Our preliminary in-vitro and ex-vivo experiments documented the ability of Malassezin to decrease skin pigmentation. The objective of this randomized, double blind, controlled study was to investigate the skin lightening effects of novel formulations of Malassezin for facial hyperpigmentation. This 22-week study enrolled subjects with melasma(n=8) and dyschromia(n=12) caused by photodamage. Subjects had mild, moderate, or severe hyperpigmentation. They were randomized to 1 of 4 groups including vehicle, 0.1%, 0.5%, and 1.0%. Subjects were evaluated at baseline, 2, 4, 8, 14, 18 and 22 weeks. Twenty subjects were enrolled and 16 completed the study. As early as 2 weeks, colorimetry assessments (Mexameter MX18) showed improvement. The 1.0% formulation group showed a significant percent reduction in the melanin index compared to vehicle for involved skin (2.93% vs 0.27% respectively). At 14 weeks, clinical assessments and photography using the Visia-CR (Canfield Scientific) showed that there was a decrease in facial hyperpigmentation in 69% of subjects. The lightening effects were sustained during the 8-week regression period from week 14 to week 22. Histopathological assessments( Fontana Masson staining) showed a reduction in melanin. There were no clinically significant adverse events observed during the study. This proof of concept study documents the very novel efficacy and safety of malassezin for skin lightening.
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