Melanil in the Treatment of Melasma

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Melanil in the Treatment of Melasma

Conditions
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Melasma

Intervention / Treatment
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* Other: Melanil facial cream
* Other: Hydroquinone 2% cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Melasma Fitzpatrick's skin types I to IV Signed informed consent Given verbal agreement on protection from UV light during treatment by the usage of physical barriers (umbrellas, caps, hats, etc). Exclusion Criteria: Fitzpatrick's skin types V and VI Treatment with steroids within the duration of the clinical trial. Oral contraception within the duration of the clinical trial Usage of other cosmetics within the duration of the clinical trial Treatment with Clofazimine within the duration of the clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Melanil facial cream | Other: Melanil facial cream<br>* 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.<br>|
| Active Comparator: B<br>Hydroquinone 2% cream | Other: Hydroquinone 2% cream<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cosmetic, Facial cream, Melasma, Melanil