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Melanil in the Treatment of Melasma

2014-07-23 21:12:18 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Melasma

Intervention

Melanil facial cream, Hydroquinone 2% cream

Location

"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Havana City
Havana
Cuba
10400

Status

Active, not recruiting

Source

Catalysis SL

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:18-0400

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