Clinical trial NCT01111981: Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia
Official title: Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alopecia
Keywords: alopecia
CCCA - Central Centrifugal Cicatricial Alopecia
Lead sponsor: Callender Center for Clinical Research
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.)

Primary outcomes:
measure: Improvement of pruritis, tenderness, and pain
timeFrame: 4 months
Secondary outcomes:
measure: Absence of inflammation on biopsy
timeFrame: 4 months
Other outcomes:
Locations:
city: Mitchellville
country: United States
facility: Callender Center for Clinical Research
state: Maryland
Study officials:
affiliation: Callender Skin for Clinical Research
name: Valerie Callender, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Callender Center for Clinical Research
name: Cherie Young, M.D.
role: STUDY_DIRECTOR
References:
citation: Callender VD, Kazemi A, Young CM, Chappell JA, Sperling LC. Safety and Efficacy of Clobetasol Propionate 0.05% Emollient Foam for the Treatment of Central Centrifugal Cicatricial Alopecia. J Drugs Dermatol. 2020 Jul 1;19(7):719-724. doi: 10.36849/JDD.2020.5201.