Pseudofolliculitis BarbaePhase 2NCT00176995
Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae
A Phase 2 study testing 15% Eflornithine Hdyrochloride in people with Pseudofolliculitis Barbae, run by Hordinsky, Maria K., MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pseudofolliculitis Barbae
- What is being tested?
- 15% Eflornithine Hdyrochloride
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Oct 2000
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this 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
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.
- Conditions
- Pseudofolliculitis Barbae
- Being tested
- 15% Eflornithine Hdyrochloride
- Medical subject headings
- pseudofolliculitis barbae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15% Eflornithine HdyrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 1999
- Study completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudofolliculitis BarbaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Hordinsky, Maria K., MD
- Investigators
- Maria Hordinsky, MD, Principal investigator, University of MinnesotaMarna Ericson, Ph D, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176995
- Sponsor's protocol ID
- 9902M00119
- Status last verified
- Nov 2006
- First submitted
- 12 Sep 2005
- Last updated
- 13 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00176995
- Acronym / sponsor ID
- 9902M00119
- Conditions
- Pseudofolliculitis Barbae
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Hordinsky, Maria K., MD
- Study start
- Mar 1999
- Study completion
- Oct 2000
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15% Eflornithine Hdyrochloride | Drug | – |
Primary outcome
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.
1 secondary outcome
Observation of changes in binding of this lectin or orthocortical cells of beard hair follicles in African American men before and after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2006.
Related trials for Pseudofolliculitis Barbae
Active, not recruiting
Shaving Satisfaction in Males With Skin Irritation From Shaving
Pseudofolliculitis Barbae
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Hordinsky, MD principal investigator
University of Minnesota
Marna Ericson, Ph D principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 15% Eflornithine Hdyrochloride in people with Pseudofolliculitis Barbae, run by Hordinsky, Maria K., MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2006.