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Evaluation of the Efficacy of Cysteamine 5% Cream in the Treatment of Epidermal Melasma: A Randomized Double-Blind Placebo-Controlled Trial Publisher Pubmed



Mansouri P1, 2 ; Farshi S1, 2 ; Hashemi Z3 ; Kasraee B4
Authors
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Authors Affiliations
  1. 1. Department of Dermatology, Imam Hospital Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Deputy of Health Services, Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Scientis Pharma SA, Geneva, Switzerland

Source: British Journal of Dermatology Published:2015


Abstract

Background Melasma is a difficult-to-treat hyperpigmentary disorder. While cysteamine is a known potent depigmenting agent, its efficacy in treating melasma has not been tested. Objectives To study the efficacy of cysteamine 5% cream in the treatment of patients with epidermal melasma. Methods In this double-blind randomized study, participating patients (n = 50) received either placebo (n = 25) or cysteamine cream (n = 25). Cysteamine cream or placebo were applied on the lesions once a day at bedtime over 4 months. The efficacy of treatments was determined through Mexameter skin colorimetry, Melasma Area Severity Index (MASI) score, Investigator's Global Assessment (IGA) and patients' questionnaires, all performed at baseline and after 2 and 4 months of treatment. Results At baseline, the mean differences between pigmented and normal skin (calculated by Mexameter) were 75·2 ± 37 and 68·9 ± 31 in the cysteamine and placebo groups, respectively. After 2 and 4 months of application of cysteamine and placebo cream, the mean differences were 39·7 ± 16·6 and 26·2 ± 16 in the cysteamine group, and 63·8 ± 28·6 and 60·7 ± 27·3 in the placebo group, respectively. Statistically significant differences were found between the group outcomes at both points (P = 0·001 and P < 0·001). At the end of the treatment, the MASI scores were significantly lower in the cysteamine group vs. placebo (7·2 ± 5·5 vs. 11·6 ± 7·9, P = 0·02). The IGA and patients' viewpoints indicated significant efficacy of cysteamine cream vs. placebo. Conclusions Cysteamine cream showed significant efficacy in the treatment of melasma. What's already known about this topic? Melasma is an acquired hyperpigmentary disease that is hard to treat. Cysteamine is known to be a depigmenting agent, but has not been studied in the treatment of melasma. What does this study add? Cysteamine showed greater efficacy than placebo in the treatment of melasma, at both 2 and 4 months. Cysteamine showed significant efficacy both by Investigator's Global Assessment and patients' viewpoints. © 2014 British Association of Dermatologists.