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

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

Sponsors

Lead Sponsor: Callender Center for Clinical Research

Source Callender Center for Clinical Research
Brief Summary

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

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.

Overall Status Unknown status
Start Date October 2009
Completion Date October 2010
Primary Completion Date February 2010
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Improvement of pruritis, tenderness, and pain 4 months
Secondary Outcome
Measure Time Frame
Absence of inflammation on biopsy 4 months
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Clobetasol Propionate 0.05% Emollient Foam

Description: Clobetasol Propionate 0.05% E Foam to be applied to affected area once a day for 16 weeks

Other Name: Olux-E

Eligibility

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.)

Gender: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Lynn Carter, BA

Phone: 301-249-0970

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Callender Center for Clinical Research Lynn Carter, BA 301-249-0970 [email protected]
Location Countries

United States

Verification Date

April 2010

Responsible Party

Name Title: Valerie Callender, M.D.

Organization: Callender Center for Clinical Research

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov

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