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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Melanil facial cream |
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| B | Active Comparator | Hydroquinone 2% cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melanil facial cream | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52. | 52 weeks | |
| Photographs, at the beginning of the study and at weeks 8, 12 and 52. | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfredo Abreu Daniel, PhD | "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital | Havana | La Habana | 10400 | Cuba |
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C031927 | hydroquinone |
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| Hydroquinone 2% cream | Other | 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. |
|