A Phase 3 interventional study of Melanil facial cream and Hydroquinone 2% cream in Melasma, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-05-04.
Sponsored by Catalysis SL · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Melanil facial cream
Other: Melanil facial cream
Hydroquinone 2% cream
Other: Hydroquinone 2% cream
Dosage commensurate with surface to be treated, Melanil facial cream (Topical use), twice a day, for 8 weeks. The affected surface will be washed and dried before application with a thin layer of Melanil facial cream.
Dosage commensurate with surface to be treated, Hydroquinone 2% cream (Topical use), twice a day, for 8 weeks. The affected surface will be washed and dried before application with a thin layer of Hydroquinone 2% cream.
MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52.
Time frame: 52 weeks
Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52.
Time frame: 52 weeks
Photographs, at the beginning of the study and at weeks 8, 12 and 52.
Time frame: 52 weeks
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Catalysis SL