Clinical Trial: Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia
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 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.
Sponsor: Callender Center for Clinical Research
Current Primary Outcome: Improvement of pruritis, tenderness, and pain [ Time Frame: 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Absence of inflammation on biopsy [ Time Frame: 4 months ]
Original Secondary Outcome: Same as current
Information By: Callender Center for Clinical Research
Dates:
Date Received: April 26, 2010
Date Started: October 2009
Date Completion: October 2010
Last Updated: April 27, 2010
Last Verified: April 2010
