A clinical, prospective, randomized, double-blind trial comparing skin whitening complex with hydroquinone vs. placebo in the treatment of melasma.

Objectives: To compare, in a double-blind, randomized, prospective study, the clinical improvement of hyperpigmentation in 30 patients with melasma using hydroquinone or skin whitening complex topically on one side of the face vs. a placebo cream on the other. The study was performed during the period November 2000 to March 2001 at the Federal University of São Paulo, Escola Paulista de Medicina.

Methods: Thirty patients received three tubes of cream and were divided into two groups: group 1, one tube containing hydroquinone 4% cream and one tube containing placebo to be applied to opposite sides of the face at night, and standardized sunscreen [sun protection factor (SPF) 25] for daily use; group 2, one tube containing skin whitening complex 5% cream and one tube containing placebo to be applied to opposite sides of the face at night, and standardized sunscreen (SPF 25). All of the tubes had the same appearance and the creams had the same characteristics. The only person who knew what was being used by each patient on each side of the face was the pharmacist. A professional photographer took photographs before and after treatment, which lasted for 3 months. Clinical evaluation was performed by two independent observers and by the patients themselves. Statistical evaluation was by the chi-squared and kappa methods.

Results: Twenty-five patients completed the study, with an overall improvement of 72% in comparison with placebo. Group 1 (hydroquinone and placebo) presented an improvement of 76.9% with 25% side-effects, and group 2 (skin whitening complex and placebo) presented an improvement of 66.7% with 0% side-effects.

Conclusions: Both depigmentation agents were useful in the treatment of melasma. The hydroquinone group presented more collateral effects than the skin whitening complex group. Considering that the patients showed Fitzpatrick skin types IV to VI and the study was conducted in the summer, skin whitening complex seems to be an excellent choice for the treatment of melasma.