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

NCT ID: NCT01111981

Last Updated: 2010-04-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Alopecia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Intervention Type DRUG

Other Intervention Names

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Olux-E

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Callender Center for Clinical Research

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lynn Carter, BA

Role: CONTACT

301-249-0970

Cherie Young, M.D.

Role: CONTACT

301-249-0970

Facility Contacts

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Lynn Carter, BA

Role: primary

301-249-0970

Niccole Mathews

Role: backup

301-249-0970

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.

Reference Type DERIVED
PMID: 32726554 (View on PubMed)

Other Identifiers

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VDC2009O

Identifier Type: -

Identifier Source: org_study_id

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