Melanil in the Treatment of Melasma

Efficacy of Melanil in the Treatment of Melasma

The purpose of the study is to assess the efficacy of Melanil facial cream in the treatment of melasma. The duration of this double-blind phase 3 clinical trial will be 54 weeks. The control group will receive treatment with Hydroquinone (2%). The estimated number of subjects to be recruited and randomized for the study is 150. The primary outcome measure: Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, 12 and 54. Photographs taken at the beginning of the study and at weeks 8, 12 and 54 will be evaluated by two independent dermatologists. Occurrence of adverse effects will also be assessed.

Inclusion Criteria:

• Clinical diagnosis of Melasma
• Fitzpatrick's skin types I to IV
• Signed informed consent
• Given verbal agreement on protection from UV light during treatment by the usage of physical barriers (umbrellas, caps, hats, etc).

Exclusion Criteria:

• Fitzpatrick's skin types V and VI
• Treatment with steroids within the duration of the clinical trial.
• Oral contraception within the duration of the clinical trial
• Usage of other cosmetics within the duration of the clinical trial
• Treatment with Clofazimine within the duration of the clinical trial