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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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Melanil facial cream, Hydroquinone 2% cream
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Active, not recruiting
Published on BioPortfolio: 2014-07-23T21:12:18-0400
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...