TITLE:
A Double-Blind, Placebo Controlled Clinical Trial Evaluating the Efficacy and Safety of a New Skin Whitening Combination in Patients with Chloasma
AUTHORS:
Xi Wang, Zhaoxia Li, Dan Zhang, Li Li, Seite Sophie
KEYWORDS:
Chloasma; Melasma; Hemi-MASI; Skin-Whitening; Ferulic Acid; Ginkgo Biloba; LHA; Niacinamide; Thermal Spring Water
JOURNAL NAME:
Journal of Cosmetics, Dermatological Sciences and Applications,
Vol.4 No.2,
March
21,
2014
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. Thissingle 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.