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

Phase 4

• Conditions: Alopecia

• Registration Number: NCT01111981
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-02
• Status Verified: 2010-04
• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-27
• Last Update Submitted: 2010-04-27
• Study First Posted: 2010-04-28
• Last Update Posted: 2010-04-28
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement of pruritis, tenderness, and pain	4 months

Secondary Outcome Measures

Name	Time	Method
Absence of inflammation on biopsy	4 months

Trial Locations

Locations (1)

Callender Center for Clinical Research; 🇺🇸 Mitchellville, Maryland, United States