Clinical Trials

Novel Supplement with Phenolic Compounds for Treatment of Melasma: Double Blind Placebo Controlled Trial Safety and Efficacy Evaluation, Corresponding Author: Downie, J. B., MD, FAAD, Image Dermatology, Montclair, NJ, USA; Journal: Dermatology and Dermatologic Diseases, 5(1).; Copyright: © 2018 Downie J, et al.

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.

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.

 
 

mMASI - NanoMD

 

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.