Back to resultsEffect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae
Primary Purpose
Pseudofolliculitis Barbae
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
15% Eflornithine Hdyrochloride
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Pseudofolliculitis Barbae
Eligibility Criteria
Inclusion Criteria: Males age 18 or older of African American descent. History of PFB localized to the beard area of at least 2 years duration confirmed by a dermatologist. PFB grade 3 (ingrown hairs and 20 or more papules of 2mm or greater in diameter with inflammation with minimal pustules) or greater involving the beard area of the face. Customary frequency of removal of facial hair by wet shaving at least once per week. Exclusion Criteria: Use of topical medications on the face within 2 weeks prior to treatment. Use of systemic steroids, antibiotics, lithium or isotretinoin within 2 months prior to pretreatment. Use of etretinate or acitretin within one year prior to pretreatment. Use of systemic antiandrogens, spironolactone, growth hormone, immunostimulants. immunosuppressants, 5-alpha reductase inhibitors. minoxidil dehydroepiandrosterone (DHEA) or other medications considered to have an effect on hair growth within 6 months prior to pretreatment. Use of physical hair removal techniques (laser, electrolysis, epilation) or chemical removal products (depilatories, waxing, sugaring) within 4 weeks prior to pretreatment. Presence of bacterial infections in the beard area including abscesses (3 or more) covering greater than 10% of the face and/or severe inflammatory acne.
Sites / Locations
- University of Minnesota
Outcomes
Primary Outcome Measures
Observation of changes in actin filament/stress fibers orientation formation and location in the beard hair follicles in African American men before and after treatment.
Secondary Outcome Measures
Observation of changes in binding of this lectin or orthocortical cells of beard hair follicles in African American men before and after treatment.
Full Information
NCT ID
NCT00176995
First Posted
September 12, 2005
Last Updated
November 8, 2006
Sponsor
Hordinsky, Maria K., MD
1. Study Identification
Unique Protocol Identification Number
NCT00176995
Brief Title
Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae
Official Title
Phase II, Open-Label Study of the Effect of 15% Eflornithine Hydrochloride Cream on Facial Hair of Men of African-American Descent With Pseudofolliculitis Barbae: A Laser Scanning Confocal Microscopy and Video Imaging Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hordinsky, Maria K., MD
4. Oversight
5. Study Description
Brief Summary
This trial is designed to gain insight into the mechanism of action of eflornithine hydrochloride in men and to aid in determining if this compound is deserving of further development for a pseudofolliculitis barbae indication. This study will also provide knowledge which will be useful in designing future PFB trials in this indication is pursued.
Detailed Description
The proposed mechanism of action of eflornithine hydrochloride for treatment of hair growth is that it reduces the rate of cell growth within the hair follicle by inhibition of the enzyme ornithine decarboxylase (ODC). In preclinical studies eflornithine hydrochloride was shown to inhibit ODC and decrease hair mass. In sheep, systemic inhibition of ODC by eflornithine hydrochloride markedly altered not only the length and diameter of hair fibers, but also the portion of the hair fiber cross-section occupied by paracortical cells, which are primarily found in straight hairs. In a Phase II study evaluating the effect of the drug in the treatment of female hirsutism, it was anecdotally noted that those who also had PFB showed an improvement in this condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudofolliculitis Barbae
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
15% Eflornithine Hdyrochloride
Primary Outcome Measure Information:
Title
Observation of changes in actin filament/stress fibers orientation formation and location in the beard hair follicles in African American men before and after treatment.
Secondary Outcome Measure Information:
Title
Observation of changes in binding of this lectin or orthocortical cells of beard hair follicles in African American men before and after treatment.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males age 18 or older of African American descent.
History of PFB localized to the beard area of at least 2 years duration confirmed by a dermatologist.
PFB grade 3 (ingrown hairs and 20 or more papules of 2mm or greater in diameter with inflammation with minimal pustules) or greater involving the beard area of the face.
Customary frequency of removal of facial hair by wet shaving at least once per week.
Exclusion Criteria:
Use of topical medications on the face within 2 weeks prior to treatment.
Use of systemic steroids, antibiotics, lithium or isotretinoin within 2 months prior to pretreatment. Use of etretinate or acitretin within one year prior to pretreatment.
Use of systemic antiandrogens, spironolactone, growth hormone, immunostimulants. immunosuppressants, 5-alpha reductase inhibitors. minoxidil dehydroepiandrosterone (DHEA) or other medications considered to have an effect on hair growth within 6 months prior to pretreatment.
Use of physical hair removal techniques (laser, electrolysis, epilation) or chemical removal products (depilatories, waxing, sugaring) within 4 weeks prior to pretreatment.
Presence of bacterial infections in the beard area including abscesses (3 or more) covering greater than 10% of the face and/or severe inflammatory acne.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marna Ericson, Ph D
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae
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