Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia
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ClinicalTrials.gov Identifier: NCT01111981 |
Recruitment Status : Unknown
Verified April 2010 by Callender Center for Clinical Research.
Recruitment status was: Recruiting
First Posted : April 28, 2010
Last Update Posted : April 28, 2010
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alopecia | Drug: Clobetasol Propionate 0.05% Emollient Foam | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | October 2009 |
Estimated Primary Completion Date : | February 2010 |
Estimated Study Completion Date : | October 2010 |

- Drug: Clobetasol Propionate 0.05% Emollient Foam
Clobetasol Propionate 0.05% E Foam to be applied to affected area once a day for 16 weeksOther Name: Olux-E
- Improvement of pruritis, tenderness, and pain [ Time Frame: 4 months ]
- Absence of inflammation on biopsy [ Time Frame: 4 months ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111981
Contact: Lynn Carter, BA | 301-249-0970 | clinresearch@callenderskin.com | |
Contact: Cherie Young, M.D. | 301-249-0970 | clinresearch@callenderskin.com |
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 |
Principal Investigator: | Valerie Callender, M.D. | Callender Skin for Clinical Research | |
Study Director: | Cherie Young, M.D. | Callender Center for Clinical Research |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Valerie Callender, M.D., Callender Center for Clinical Research |
ClinicalTrials.gov Identifier: | NCT01111981 |
Other Study ID Numbers: |
VDC2009O |
First Posted: | April 28, 2010 Key Record Dates |
Last Update Posted: | April 28, 2010 |
Last Verified: | April 2010 |
alopecia CCCA - Central Centrifugal Cicatricial Alopecia |
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 |