A Double-Blind, Placebo Controlled Clinical Trial Evaluating the Efficacy and Safety of a New Skin Whitening Combination in Patients with Chloasma

Abstract

Melasma (or chloasma) is a hyperpigmentation disorder predominantly affecting sun-exposed skin in women, and is often refractory to treatment. The objective was to evaluate the efficacy and safety of a new whitening formula for the treatment of chloasma. This single centre, double-blind, placebo controlled, bilateral (split-face) comparison, was conducted on 44 Chinese subjects with chloasma during the winter season. The test formula was applied twice a day, for 12 weeks on left side of the face and a placebo formula on the right side of the face. Assessments included the use of the hemi-MASI (split-face Melasma Area Severity Index), both ultraviolet and standard photography, together with clinical evaluations of efficacy and safety at T0, T6 and T12 weeks. A significant difference between the 2-hemi-MASI was noticed after 6 and 12 weeks of treatment. This result was confirmed by the clinical evaluation of the dermatologists who recorded a significant improvement in the half-face treated with the new whitening formula compared with that treated with placebo (p = 0.003). The tolerance of the new formula was recorded as excellent by 82% of subjects and found to be cosmetically appealing. In this study, the new whitening formula containing ferulic acid, Ginkgo Biloba, lipohydroxyacid (LHA), niacinamide and thermal spring water was safe and significantly improved chloasma after a 3-month-treatment period compared with placebo.