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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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.
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Havana, La Habana, Cuba
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
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