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