Alopecia | Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia
Alopecia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Clobetasol Propionate 0.05% Emollient FoamClobetasol Propionate 0.05% E Foam to be applied to affected area once a day for 16 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: October 2009
Completed Date: October 2010
Phase: Phase 4
Primary Outcome: Improvement of pruritis, tenderness, and pain
Secondary Outcome: Absence of inflammation on biopsy
Study sponsors, principal investigator, and references
Principal Investigator: Valerie Callender, M.D.
Lead Sponsor: Callender Center for Clinical Research