Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae

NCT00176995 | Completed Phase 2

• 1 other identifier: 9902M00119
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudofolliculitis Barbae

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Observation of changes in binding of this lectin or orthocortical cells of beard hair follicles in African American men before and after treatment.

Interventions

15% Eflornithine Hdyrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hordinsky, Maria K., MD: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

pseudofolliculitis barbae

Study Officials

• Maria Hordinsky, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Marna Ericson, Ph D

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: ECT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 1999
• Study Completion: October 1, 2000
• Last Updated: November 13, 2006

Record last verified: 2006-11

Locations

US (1)