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

Sponsored by:	Hordinsky, Maria K., MD
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00176995

Purpose

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.

Condition	Intervention	Phase
Pseudofolliculitis Barbae	Drug: 15% Eflornithine Hdyrochloride	Phase II

Drug Information available for: Eflornithine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Minnesota:

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.

Estimated Enrollment:	15
Study Start Date:	March 1999
Estimated Study Completion Date:	October 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176995

Locations

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

Sponsors and Collaborators

Hordinsky, Maria K., MD

Investigators

Principal Investigator:	Maria Hordinsky, MD	University of Minnesota
Principal Investigator:	Marna Ericson, Ph D	University of Minnesota

More Information

Study ID Numbers:	9902M00119
Study First Received:	September 12, 2005
Last Updated:	November 8, 2006
ClinicalTrials.gov Identifier:	NCT00176995
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Facies
Eflornithine

Additional relevant MeSH terms:

Anti-Infective Agents
Trypanocidal Agents
Antiparasitic Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009