title: A pilot study using reflectance confocal microscopy (RCM) in the assessment of a novel formulation for the treatment of melasma.
abstract: BACKGROUND
  Melasma is a common pigmentary disorder caused by abnormal melanin deposits within the skin. Hydroquinone (HQ) is presently the most popular depigmenting agent, however the treatment of melasma remains unsatisfactory, resulting in a need to evaluate new depigmenting agents.
  
  
  OBJECTIVE
  The objective of this study was to assess, using standard methods and a novel technique, in vivo Reflectance Confocal Microscopy (RCM), the efficacy and safety of a new non-HQ bleaching agent Dermamelan® (Mesoestetic, Barcelona, Spain) in the treatment of melasma.
  
  
  METHODS
  Ten women with melasma were enrolled in an open-label trial lasting four months. Patients were of Fitzpatrick skin types II-IV. A non-HQ depigmenting agent (Dermamelan) was applied once-daily for three months. Melasma Area and Severity Indices (MASI) were measured. Standard and UV-light photographs were taken and in vivo RCM, which detects pigmentary changes at a cellular level, was done. Evaluations were performed before treatment, on the first, second and third month of treatment and one month after treatment. Upon cessation of the trial, patients completed a questionnaire regarding efficacy and tolerance.
  
  
  RESULTS
  At baseline, RCM detected hyperpigmented keratinocytes in all patients, dendritic cells in 2/10 patients, and melanophages in 2/10 patients. Based on the MASI score, Dermamelan treatment improved melasma by 50 percent. This was confirmed by standard and UV-light photography. Maximum therapeutic effect was usually reached by one month of treatment and was maintained at one month following its completion. Interestingly Dermamelan treatment also induced a statistically significant decrease of pigmented epidermal keratinocytes as detected by RCM. Patients with melanophages on RCM at baseline had a poorer outcome, but not those with dendritic cells. Mild irritation was the only adverse event observed during treatment. The majority of patients were satisfied with the result.
  
  
  CONCLUSIONS
  This study suggests that Dermamelan produces significant rapid improvement of melasma at a clinical and cellular level and demonstrates the potential of RCM to monitor and possibly predict efficacy of a new depigmenting agent in the treatment of melasma.
authors: Department of Dermatology, University Hospital of Nice, Nice, France.
authors: Katerina
authors: K
authors: Tsilika
authors: Jean Luc
authors: JL
authors: Levy
authors: Hee Young
authors: HY
authors: Kang
authors: Luc
authors: L
authors: Duteil
authors: Abdallah
authors: A
authors: Khemis
authors: Rosalind
authors: R
authors: Hughes
authors: Thierry
authors: T
authors: Passeron
authors: Jean Paul
authors: JP
authors: Ortonne
authors: Philippe
authors: P
authors: Bahadoran
mesh_terms: D003713:Dendritic Cells / Q000378:metabolism; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015603:Keratinocytes / Q000187:drug effects / Q000378:metabolism; D008548:Melanosis / Q000175:diagnosis / Q000188:drug therapy*; D018613:Microscopy, Confocal / Q000379:methods*; D017060:Patient Satisfaction; D010865:Pilot Projects; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents