Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia
| Registry | NCT01111981 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Callender Center for Clinical Research (Other) |
| Conditions | Alopecia |
| Interventions | Clobetasol Propionate 0.05% Emollient Foam (Drug) |
| Dates | start 2009-10-01, primary completion 2010-02-01 (estimated), completion 2010-10-01 (estimated), first posted 2010-04-28, last updated 2010-04-28 |
| Locations | 1 site in United States |
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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.
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.
Sex: Female, ages: 18 Years to 80 Years
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.)
| Facility | City | Country | Status |
|---|---|---|---|
| Callender Center for Clinical Research | Mitchellville, Maryland | United States | Recruiting |