Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia
Status: | Completed |
---|---|
Conditions: | Dermatology, Hair Loss |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/2/2016 |
Start Date: | October 2009 |
End Date: | October 2010 |
Contact: | Lynn Carter, BA |
Email: | clinresearch@callenderskin.com |
Phone: | 301-249-0970 |
Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia
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.
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.
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.
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.)
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