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

November 8, 2006 updated by: Hordinsky, Maria K., MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Educational/Counseling/Training
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hordinsky, Maria K., MD

Investigators

  • Principal Investigator: Marna Ericson, Ph D, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Study Completion

October 1, 2000

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

November 13, 2006

Last Update Submitted That Met QC Criteria

November 8, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9902M00119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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