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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01111981
Recruitment Status : Unknown
Verified April 2010 by Callender Center for Clinical Research.
Recruitment status was:  Recruiting
First Posted : April 28, 2010
Last Update Posted : April 28, 2010
Sponsor:
Information provided by:
Callender Center for Clinical Research

April 26, 2010
April 28, 2010
April 28, 2010
October 2009
February 2010   (Final data collection date for primary outcome measure)
Improvement of pruritis, tenderness, and pain [ Time Frame: 4 months ]
Same as current
No Changes Posted
Absence of inflammation on biopsy [ Time Frame: 4 months ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia
Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia

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.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alopecia
Drug: 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 Name: Olux-E
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Same as current
October 2010
February 2010   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01111981
VDC2009O
No
Not Provided
Not Provided
Valerie Callender, M.D., Callender Center for Clinical Research
Callender Center for Clinical Research
Not Provided
Principal Investigator: Valerie Callender, M.D. Callender Skin for Clinical Research
Study Director: Cherie Young, M.D. Callender Center for Clinical Research
Callender Center for Clinical Research
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP