Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
|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|
- 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.
- Observation of changes in binding of this lectin or orthocortical cells of beard hair follicles in African American men before and after treatment.
|Study Start Date:||March 1999|
|Estimated Study Completion Date:||October 2000|
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.
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Maria Hordinsky, MD||University of Minnesota - Clinical and Translational Science Institute|
|Principal Investigator:||Marna Ericson, Ph D||University of Minnesota - Clinical and Translational Science Institute|