Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia
NCT ID: NCT01111981
Last Updated: 2010-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2009-10-31
2010-10-31
Brief Summary
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Clobetasol Propionate 0.05% E Foam in the treatment of Central Centrifugal
Cicatricial Alopecia.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Clobetasol Propionate 0.05% Emollient Foam
Clobetasol Propionate 0.05% E Foam to be applied to affected area once a day for 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Score 0 - 1 on Scale/Questionnaire
* 18 years of age or older
* Women of African descent
Exclusion Criteria
* 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.)
18 Years
80 Years
FEMALE
No
Sponsors
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Callender Center for Clinical Research
OTHER
Responsible Party
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Callender Center for Clinical Research
Principal Investigators
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Valerie Callender, M.D.
Role: PRINCIPAL_INVESTIGATOR
Callender Skin for Clinical Research
Cherie Young, M.D.
Role: STUDY_DIRECTOR
Callender Center for Clinical Research
Locations
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Callender Center for Clinical Research
Mitchellville, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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VDC2009O
Identifier Type: -
Identifier Source: org_study_id
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