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

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City:		Mitchellville
State:		Maryland
Zip Code:		20721

Conditions:		Alopecia
Purpose:		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.
Study Summary:		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.
Criteria:		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.)
NCT ID:		NCT01111981
Primary Contact:		Principal Investigator Valerie Callender, M.D. Callender Skin for Clinical Research Lynn Carter, BA Phone: 301-249-0970 Email: clinresearch@callenderskin.com
Backup Contact:		Email: clinresearch@callenderskin.com Cherie Young, M.D. Phone: 301-249-0970
Location Contact:		Mitchellville, Maryland 20721 United States Lynn Carter, BA Phone: 301-249-0970 Email: clinresearch@callenderskin.com Site Status: Recruiting

Data Source:		ClinicalTrials.gov
Date Processed:		May 20, 2013
Modifications to this listing:		Only selected fields are shown, please use the link below to view all information about this clinical trial.
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