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

Alopecia Clinical Trial

Official title:

Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01111981
• Other study ID #: VDC2009O
• Status: Recruiting
• Phase: Phase 4
• First received: April 26, 2010
• Last updated: April 27, 2010
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: April 2010
• Source: Callender Center for Clinical Research
• Contact: Lynn Carter, BA
• Phone: 301-249-0970
• Email: clinresearch[@]callenderskin.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

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

Locations

Country	Name	City	State
United States	Callender Center for Clinical Research	Mitchellville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Callender Center for Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of pruritis, tenderness, and pain		4 months	Yes
Secondary	Absence of inflammation on biopsy		4 months	Yes

External Links

•   Home Page to the Callender Skin & Laser Center that includes "Research Studies" section