Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia

Study Overview
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Brief Summary
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The purpose of this study is to ascertain the safety and efficacy of Clobetasol Propionate 0.05% E Foam in the treatment of Central Centrifugal Cicatricial Alopecia.

Detailed Description
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Central Centrifugal Cicatricial Alopecia (CCCA) is an inflammation-induced hair loss starting in the central scalp and progressing centrifugally. The cause of CCCA is unknown. Early diagnosis and treatment is essential to stop or slow the progression of scarring and permanent hair loss. Once scarring occurs, the hair follicles are obliterated and the hair cannot regrow. Thus, anti-inflammatory medications are used to decrease inflammation. Current treatment includes topical and intralesional corticosteroids, oral antibiotics, and hair transplantation, all which may take months to years to show improvement. There is no evidence-based medicine on how to treat primary cicatricial alopecias. Clobestasol Propionate 0.05% Emollient Foam is an FDA-approved and marketed topical corticosteroid for the treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid- responsive dermatoses of the scalp. Many studies found the foam to be less irritating than the original formulation.

Official Title
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Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia

Conditions
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Alopecia

Intervention / Treatment
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* Drug: Clobetasol Propionate 0.05% Emollient Foam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with CCCA, treated or untreated Score 0 - 1 on Scale/Questionnaire 18 years of age or older Women of African descent Exclusion Criteria: Score > 1 on Scale/Questionnaire Alopecias other than CCCA, including alopecia arreata, lichen planopilaris, trichotillomania, and traction alopecia History of hair transplantation Children less than 18 years of age Males Women of non-African descent Pregnancy or breastfeeding. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms) Anti-dandruff shampoo within 30 days Anti-inflammatory medications such as antibiotics (doxycycline, minocycline, rifampin, etc.), steroids (oral prednisone, topical corticosteroids,etc.), NSAIDs (ibuprofen, aspirin, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Clobetasol Propionate 0.05% Emollient Foam|Clobetasol Propionate 0.05% E Foam to be applied to affected area once a day for 16 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of pruritis, tenderness, and pain |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of inflammation on biopsy |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alopecia, CCCA - Central Centrifugal Cicatricial Alopecia