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

Primary Purpose

Alopecia

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clobetasol Propionate 0.05% Emollient Foam
Sponsored by
Callender Center for Clinical Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia focused on measuring alopecia, CCCA - Central Centrifugal Cicatricial Alopecia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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.)

Sites / Locations

  • Callender Center for Clinical ResearchRecruiting

Outcomes

Primary Outcome Measures

Improvement of pruritis, tenderness, and pain

Secondary Outcome Measures

Absence of inflammation on biopsy

Full Information

First Posted
April 26, 2010
Last Updated
April 27, 2010
Sponsor
Callender Center for Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT01111981
Brief Title
Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia
Official Title
Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Callender Center for Clinical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia
Keywords
alopecia, CCCA - Central Centrifugal Cicatricial Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clobetasol Propionate 0.05% Emollient Foam
Other Intervention Name(s)
Olux-E
Intervention Description
Clobetasol Propionate 0.05% E Foam to be applied to affected area once a day for 16 weeks
Primary Outcome Measure Information:
Title
Improvement of pruritis, tenderness, and pain
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Absence of inflammation on biopsy
Time Frame
4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lynn Carter, BA
Phone
301-249-0970
Email
clinresearch@callenderskin.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cherie Young, M.D.
Phone
301-249-0970
Email
clinresearch@callenderskin.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Callender, M.D.
Organizational Affiliation
Callender Skin for Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cherie Young, M.D.
Organizational Affiliation
Callender Center for Clinical Research
Official's Role
Study Director
Facility Information:
Facility Name
Callender Center for Clinical Research
City
Mitchellville
State/Province
Maryland
ZIP/Postal Code
20721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Carter, BA
Phone
301-249-0970
Email
clinresearch@callenderskin.com
First Name & Middle Initial & Last Name & Degree
Niccole Mathews
Phone
301-249-0970
Email
clinresearch@callenderskin.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32726554
Citation
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.
Results Reference
derived
Links:
URL
http://www.callenderskin.com
Description
Home Page to the Callender Skin & Laser Center that includes "Research Studies" section

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

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