Clinical evaluation of efficacy, safety and tolerability of cysteamine 5% cream in comparison with modified Kligman's formula in subjects with epidermal melasma: A randomized, double-blind clinical trial study.

ABSTRACT

BACKGROUND: Kligman's formula (KF) remains to date the dermatologists' treatment of choice for melasma. This study was aimed at the evaluation of the effectiveness of Modified Kligman's formula (MKF) in comparison with cysteamine 5% cream on the severity of epidermal melasma. MATERIALS AND METHODS: A total of 50 subjects with epidermal melasma were included in this double-blind, randomized trial study. Subjects received either cysteamine 5% cream or an MKF (4% hydroquinone, 0.05% retinoic acid and 0.1% betamethasone). Cysteamine cream (applied once daily, 15 minutes exposure) or MKF (applied once daily, whole night exposure) were used by the subjects over four consecutive months. The efficacy of the treatments was determined through the modified Melasma Area Severity Index (mMASI) score, the Investigator's Global Assessment (IGA) and patient questionnaires. RESULTS: The mean (SD) age of the subjects was 34.96 (6.17) and 35.76 (5.23) years for cysteamine and MKF group, respectively. The mean mMASI score after 4 months was 7.04 (2.23) in the MKF group and 6.09 (2.01) in the cysteamine group. At both prospective evaluation points (2 months, 4 months), the percentage reduction in mMASI score was approximately 9% greater by cysteamine cream as compared to MKF, and these differences were statistically significant (P = .005 and .001 respectively). CONCLUSION: Cysteamine 5% cream showed greater efficacy as compared to MKF. It is thus proposed that cysteamine 5% cream is more effective than MKF in the treatment of melasma, with the advantage of being significantly better tolerated.