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
Recruitment status was Recruiting
Sponsor:
Callender Center for Clinical Research
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
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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
Congenital Alopecia X-linked
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:
Detailed Description:
-
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
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
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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
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:
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 Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Skin Diseases Clobetasol |
Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015