Double Blind Placebo Controlled Trial to Evaluate of the Effectiveness of a Dietary Supplement Rich in Carotenoids as Adjunct to Topical Lightening Cream for the Treatment of Melasma: A Pilot Study

Objectives: To evaluate the efficacy of an oral supplement containing carotenoids as an adjunct to a topical cosmetic lightening cream for the treatment of melasma. Methods: 44 subjects with melasma were recruited into a double-blinded, randomized, placebo controlled trial over 84 days at the Singapore National Skin Centre, to receive either an oral dietary supplement containing carotenoids or a placebo. All were prescribed a commercially available cream. Patients were assessed at onset, day 54 and day 84 by the Modified Melasma area and Severity Index (mMASI), photographic documentation, melanin and erythema indexes using a Mexameter®. Results: 44 patients completed the study. The median mMASI score fell significantly in both groups (both p<0.001). There was a greater decrease seen in those who received the oral supplement group (-2.1 vs -1.8, p <0.379). The erythema score showed significant improvements in both groups, with greater improvement in the group on the oral supplement, compared to placebo (median difference = -30, p =0.018, vs median difference = -20, p =0.020). Conclusion: Oral supplements containing carotenoids are potential adjuncts in melasma treatment. 1.5 Limitations: Small sample size and short study duration limit the observations noted in this study. Further larger-scale studies are required.