Evaluation of the efficacy of cysteamine 5% cream in the treatment of epidermal melasma: a randomized double‐blind placebo‐controlled trial

Summary

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.