Status:
COMPLETED
Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae
Lead Sponsor:
Hordinsky, Maria K., MD
Conditions:
Pseudofolliculitis Barbae
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 pseudofoll...
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 de...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 1999
Trial Type :
INTERVENTIONAL
End Date :
October 1 2000
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00176995
Start Date
March 1 1999
End Date
October 1 2000
Last Update
November 13 2006
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455