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:

Drug Information available for: Clobetasol propionate

Genetic and Rare Diseases Information Center resources: Central Centrifugal Cicatricial Alopecia Pseudopelade of Brocq

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:

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Dermatologic Agents

ClinicalTrials.gov processed this record on September 28, 2016

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