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CompletedNCT00176995Updated Nov 13, 2006

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

A Phase 2 interventional study of 15% Eflornithine Hdyrochloride in Pseudofolliculitis Barbae, sponsored by Hordinsky, Maria K., MD. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-11-13.

Sponsored by Hordinsky, Maria K., MD · Phase 2, Interventional, and Educational/counseling/training

Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Pseudofolliculitis Barbae
03

In context

Lead sponsor

Hordinsky, Maria K., MD is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Educational/counseling/training
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants

Interventions

  • Drug15% Eflornithine Hdyrochloride
06

What researchers measure

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.

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00176995
Lead sponsor
Hordinsky, Maria K., MD
First posted
Sep 15, 2005
Start date
Mar 1999
Completion
Oct 2000
Last update
Nov 13, 2006

Study contacts

Maria Hordinsky, MD
principal investigator · University of Minnesota
Marna Ericson, Ph D
principal investigator · University of Minnesota
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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