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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Callender Center for Clinical Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Callender Center for Clinical Research
ClinicalTrials.gov Identifier:
NCT01111981
First received: April 26, 2010
Last updated: April 27, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Alopecia
 Drug: Clobetasol Propionate 0.05% Emollient Foam
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Callender Center for Clinical Research:

Primary Outcome Measures:
  • Improvement of pruritis, tenderness, and pain [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Absence of inflammation on biopsy [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111981

Contacts
Contact: Lynn Carter, BA 301-249-0970 clinresearch@callenderskin.com
Contact: Cherie Young, M.D. 301-249-0970 clinresearch@callenderskin.com

Locations
United States, Maryland
Callender Center for Clinical Research Recruiting
Mitchellville, Maryland, United States, 20721
Contact: Lynn Carter, BA     301-249-0970     clinresearch@callenderskin.com    
Contact: Niccole Mathews     301-249-0970     clinresearch@callenderskin.com    
Sponsors and Collaborators
Callender Center for Clinical Research
Investigators
Principal Investigator: Valerie Callender, M.D. Callender Skin for Clinical Research
Study Director: Cherie Young, M.D. Callender Center for Clinical Research
  More Information

Additional Information:
Home Page to the Callender Skin & Laser Center that includes "Research Studies" section  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Valerie Callender, M.D., Callender Center for Clinical Research
ClinicalTrials.gov Identifier: NCT01111981     History of Changes
Other Study ID Numbers: VDC2009O
Study First Received: April 26, 2010
Last Updated: April 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Callender Center for Clinical Research:
alopecia
CCCA - Central Centrifugal Cicatricial Alopecia

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Clobetasol
Emollients
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013