Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae
Tracking Information | |||||||||
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First Received Date ICMJE | September 12, 2005 | ||||||||
Last Updated Date | November 8, 2006 | ||||||||
Start Date ICMJE | March 1999 | ||||||||
Primary Completion Date | |||||||||
Current Primary Outcome Measures ICMJE |
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. | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00176995 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
Observation of changes in binding of this lectin or orthocortical cells of beard hair follicles in African American men before and after treatment. | ||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae | ||||||||
Official Title ICMJE | 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 | ||||||||
Brief 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. |
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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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training |
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Condition ICMJE | Pseudofolliculitis Barbae | ||||||||
Intervention ICMJE | Drug: 15% Eflornithine Hdyrochloride | ||||||||
Study Arm (s) | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Enrollment ICMJE | 15 | ||||||||
Completion Date | October 2000 | ||||||||
Primary Completion Date | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00176995 | ||||||||
Other Study ID Numbers ICMJE | 9902M00119 | ||||||||
Has Data Monitoring Committee | |||||||||
Responsible Party | |||||||||
Study Sponsor ICMJE | Hordinsky, Maria K., MD | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | University of Minnesota - Clinical and Translational Science Institute | ||||||||
Verification Date | November 2006 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |