title: Evaluation of the efficacy of cysteamine 5% cream in the treatment of epidermal melasma: a randomized double-blind placebo-controlled trial.
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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Department of Dermatology, Imam Hospital, Tehran University of Medical Sciences, Tehran, Iran.|Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: P
authors.initials: P
authors.lastname: Mansouri
authors.affiliation: Department of Dermatology, Imam Hospital, Tehran University of Medical Sciences, Tehran, Iran.|Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: S
authors.initials: S
authors.lastname: Farshi
authors.affiliation: Deputy of Health Services, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Z
authors.initials: Z
authors.lastname: Hashemi
authors.affiliation: Scientis Pharma SA, Geneva, Switzerland.
authors.forename: B
authors.initials: B
authors.lastname: Kasraee
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D003543:Cysteamine / Q000008:administration & dosage* / Q000009:adverse effects; D065104:Cystine Depleting Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008548:Melanosis / Q000188:drug therapy*; D008875:Middle Aged; D009824:Ointments / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D065104:Cystine Depleting Agents; D009824:Ointments; D003543:Cysteamine