A double-blind, comparative, placebo-controlled study of the efficacy and tolerability of 4% hydroquinone as a depigmenting agent in melasma

Abstract

AIM: The objective of this study was to evaluate the efficacy and tolerability of hydroquinone 4% cream with sunscreens, controlled by placebo, in the treatment of melasma. METHODS: A total of 48 patients were randomly chosen, 24 in the hydroquinone 4% group and 24 in the placebo group. Patients were instructed to use and apply additional sunscreen. The treatment lasted 12 weeks, with an evaluation of efficacy, tolerability and photographs taken every 3 weeks. Efficacy was classified as 'total improvement', 'partial improvement' or 'failure'. Tolerability was classified as 'excellent', 'good', 'fair' or 'poor'. RESULTS: The difference between the efficacy of the hydroquinone 4% and placebo groups was statistically significant. In the hydroquinone group, 40% of the patients showed complete disappearance of spots at the end of the treatment and there was no therapeutic failure reported. In the placebo group, 10% of the patients showed 'total improvement' and therapeutic failures occurred in 20% of the patients. Both treatments were well tolerated, with no serious adverse events reported. CONCLUSIONS: The results indicate that hydroquinone 4% is a safe and effective drug for the treatment of melasma and that sunscreens are important as concomitant treatment by way of preventing repigmentation and improving skin appearance. ( J Dermatol Treat (2000) 11: 173-179)