Trial | NCT01111981  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    clobetasol ...

  • Study Participants

    30
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.
Study Started
Oct 31
2009
Primary Completion
Feb 28
2010
Anticipated
Study Completion
Oct 31
2010
Anticipated
Last Update
Apr 28
2010
Estimate

Drug Clobetasol Propionate 0.05% Emollient Foam

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

  • Other names: Olux-E

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.)
No Results Posted