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

Pseudofolliculitis Barbae Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

Pseudofolliculitis Barbae

Clinical Trial Details

NCT number	NCT00176995
Study type	Interventional
Source	University of Minnesota - Clinical and Translational Science Institute
Contact
Status	Completed
Phase	Phase 2
Start date	March 1999
Completion date	October 2000

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT03043534` - Pre-Shave Gel and Brush in Pseudofolliculitis Barbae	N/A
Completed	`NCT00402129` - Low Fluence 1064nm Laser Hair Reduction for Pseudofolliculitis Barbae in Skin Types IV, V, VI	N/A
Withdrawn	`NCT04220502` - Magic Shave Powder Gold's Affects on the Occurrence of Pseudofolliculitis Barbae	Early Phase 1