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.
Highlights
Chloasma, or melasma, is a pigmentary disorder that typically appears on the face, forehead, cheeks and chin
There was no difference between the hemi-Melasma Area and Severity Index (MASI) distribution between treatment groups (7.8 ± 3.64 versus 7.95 ± 3.52 for each hemi-MASI respectively) (p = 0.595)
The cosmetic properties of the test formula were more accepted, by the patients, than for the placebo formula. In this split-face study, the new whitening formula evaluated was shown by both clinical and objective assessments to produce significant improvements in chloasma pigmentation after 12 weeks of treatment compared with a placebo formula
Summary
Melasma, is a pigmentary disorder that typically appears on the face, forehead, cheeks and chin. It occurs most frequently in women with Fitzpatrick skin type III or higher, especially those of Asian origin and is associated with negative psychological and emotional effects [1]-[7]. Chloasma can result from pregnancy or taking oral contraceptives, but it occurs spontaneously. It can affect up to 50% - 70% of pregnant women [5] [6], but genetic, ethnic (skin type), hormonal, and environmental factors, i.e. ultraviolet (UVA and UVB) exposures [6] [7], are implicated. Overall, the results are unsatisfactory, and sometimes side-effects are quite significant
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