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Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia

Information source: Callender Center for Clinical Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alopecia

Intervention: Clobetasol Propionate 0.05% Emollient Foam (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Callender Center for Clinical Research

Official(s) and/or principal investigator(s):
Valerie Callender, M.D., Principal Investigator, Affiliation: Callender Skin for Clinical Research
Cherie Young, M.D., Study Director, Affiliation: Callender Center for Clinical Research

Overall contact:
Lynn Carter, BA, Phone: 301-249-0970, Email: clinresearch@callenderskin.com


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.

Clinical Details

Official title: Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Improvement of pruritis, tenderness, and pain

Secondary outcome: Absence of inflammation on biopsy

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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Female.


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.)

Locations and Contacts

Lynn Carter, BA, Phone: 301-249-0970, Email: clinresearch@callenderskin.com

Callender Center for Clinical Research, Mitchellville, Maryland 20721, United States; Recruiting
Lynn Carter, BA, Phone: 301-249-0970, Email: clinresearch@callenderskin.com
Niccole Mathews, Phone: 301-249-0970, Email: clinresearch@callenderskin.com
Additional Information

Home Page to the Callender Skin & Laser Center that includes "Research Studies" section

Starting date: October 2009
Last updated: April 27, 2010

Page last updated: August 23, 2015

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