- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02170662
Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
The purpose of this study is to determine the effect of bimatoprost solution on scalp hair growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is not approved for the treatment of scalp hair loss and its use in this study is considered investigational which means it is still being tested in research studies.
Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hamilton-Norwood patterns of baldness IIIV, IV, V, or VA.
- Subject's hair color must have adequate contrast against scalp color to allow hair counting on macrophotography.
- Good health with normal blood tests for hematological, renal, and liver function.
- Able to return to Duke for study visits.
Exclusion Criteria:
- ECOG >1.
- Used topical or oral minoxidil in the past 6 months, oral finasteride in the past 12 months or oral dutasteride in the past 24 months.
- Taken any warfarin, heparin, or retinoid for greater than 2 weeks during the past 6 months and any in the past month.
- Taken any chemotherapy in the past 2 years.
- Used any over-the-counter (OTC) preparation that purports to help hair growth in the past four months.
- Used prostaglandins of any type in the past or currently.
- Any history of alopecia areata, cicatricial alopecia, radiation to the head, hair transplants, or scalp reductions.
- Any skin abnormalities in the target area that would effect hair growth.
- Any history of glaucoma or elevated intraocular pressure (IOP).
- Any cancer other than non-melanoma skin cancer (NMSC) in the past 2 years and all must be in remission.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active drug
During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks.
After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks.
|
Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.
|
Active Comparator: Placebo
During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks.
After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks.
|
Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Target Area Total Hair Count
Time Frame: Baseline to week 17; and week 17 to week 34
|
The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.
|
Baseline to week 17; and week 17 to week 34
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in the Target Area Terminal Hair Count
Time Frame: Baseline to week 17; and week 17 to week 34
|
Terminal hairs are those which grow beyond a cm and contribute to overall hair density.
|
Baseline to week 17; and week 17 to week 34
|
Percent Change in the Target Area Vellus Hair Count
Time Frame: Baseline to week 17; and week 17 to week 34
|
Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density.
For the most part, they have a diameter of <40 um.
They are increased in number in male pattern baldness
|
Baseline to week 17; and week 17 to week 34
|
Percent Change in Hair Diameter
Time Frame: Baseline to week 17; Week 17 to week 34
|
The percent change in hair diameter is a recent addition to the methods of assessing efficacy of hair growth promoters.
It is a measure of hair mass and does not separate out the effect on terminal and vellus hairs but rather combines the effect on both.
Since it is only terminal hairs that contributes to normal hair density, this measure does not add anything to the measures of total, terminal and vellus hair counts in terms of overall effect on hair growth and is therefore not analyzed or reported here.
|
Baseline to week 17; Week 17 to week 34
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elise Olsen, MD, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00017573
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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