Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 26, 2010
CompletedFirst Posted
Study publicly available on registry
April 28, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedApril 28, 2010
April 1, 2010
4 months
April 26, 2010
April 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement of pruritis, tenderness, and pain
4 months
Secondary Outcomes (1)
Absence of inflammation on biopsy
4 months
Interventions
Clobetasol Propionate 0.05% E Foam to be applied to affected area once a day for 16 weeks
Eligibility Criteria
You may qualify if:
- Patients with CCCA, treated or untreated
- Score 0 - 1 on Scale/Questionnaire
- years of age or older
- Women of African descent
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Callender Center for Clinical Research
Mitchellville, Maryland, 20721, United States
Related Publications (1)
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.
PMID: 32726554DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valerie Callender, M.D.
Callender Skin for Clinical Research
- STUDY DIRECTOR
Cherie Young, M.D.
Callender Center for Clinical Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 26, 2010
First Posted
April 28, 2010
Study Start
October 1, 2009
Primary Completion
February 1, 2010
Study Completion
October 1, 2010
Last Updated
April 28, 2010
Record last verified: 2010-04