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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01111981

Enrollment

Registered

2010-04-28

Start date

2009-10-31

Completion date

2010-10-31

Last updated

2010-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia

Keywords

alopecia, CCCA - Central Centrifugal Cicatricial Alopecia

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.

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.

Interventions

DRUGClobetasol Propionate 0.05% Emollient Foam

Clobetasol Propionate 0.05% E Foam to be applied to affected area once a day for 16 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame
Improvement of pruritis, tenderness, and pain	4 months

Secondary

Measure	Time frame
Absence of inflammation on biopsy	4 months

Countries

United States

Contacts

Primary ContactLynn Carter, BA

clinresearch@callenderskin.com301-249-0970

Backup ContactCherie Young, M.D.