Revista de Dermatologia e Doenças Dermatológicas

Novel Supplement with Phenolic Compounds for Treatment of Melasma: Double Blind Placebo Controlled Trial Safety and Efficacy Evaluation

Abstract

Jeanine Downie and Nurul Ain Abdullah

Background: Melasma is a chronic skin problem that causes dark, discolored patches on the skin and therefore can have adverse effects on quality of life. Recently, a novel complex was shown to decrease melasma. Specifically, the goal of the study was to prove that the formula can reduce melasma, overall hyperpigmentation and nontransient erythema.
Objectives: The primary efficacy outcome measure was a minimum of 50% improvement of the modified melasma area and severity index (mMASI) score from the baseline at the 90 day follow-up visit. Secondary outcomes were overall hyperpigmentation score collection and analyses, patient’s self-assessment regarding their non-transient erythema score when evaluated across the whole patient population at the baseline and at 90 days and the analyses of adverse events.
Methods: Forty subjects with Fitzpatrick skin types III-V were enrolled in the double-blinded, randomized, placebo controlled trial: 20 were treated over 90 days with the oral supplement and 20 received a placebo over 90 days. Subjects were assessed at onset and re-assessed at 60 and 90 days by the Modified Melasma Area and Severity Index (mMASI), photographic documentation, hyperpigmentation tool, erythema index and client satisfaction. Subjects used the product or a placebo (in tablet form) orally once a day.
Results: At 90 days, the modified melasma area and severity index score (mMASI) improved by more than 50% in 75% of cases (p<0.001), thus indicating treatment efficacy. There was a greater decrease in mMASI for the supplement group vs placebo (-3.28 for the active arm vs. -0.73 for the placebo arm, p<0.001). Furthermore, at the 90-day follow-up visit, the overall hyperpigmentation and non-transient erythema scores (p<0.001) improved significantly: by 55% and 38%, respectively. Results obtained from patients showed overall satisfaction with the therapy course and results. The product was well tolerated, with no reports of adverse events or side effects.
Conclusion: Consistent, statistically significant reductions in melasma, as measured by mMASI scores, overall hyperpigmentation and non-transient erythema scores were achieved while meeting patient expectations at the 90 day follow-up evaluation point when compared to placebo. Results from this clinical trial suggest that this oral supplement is an effective treatment for melasma and may provide an alternative treatment for overall hyperpigmentation and non-transient erythema, while meeting expectations of patients. The product was well tolerated, with no reports of adverse events or side effects.