Male Pattern Hair LossPhase 2NCT02170662
Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
A Phase 2 study testing Bimatoprost in people with Male Pattern Hair Loss and Androgenetic Alopecia, run by Duke University.
Trial summary
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™). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Male Pattern Hair Loss, Androgenetic Alopecia
- What is being tested?
- Bimatoprost
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
- Conditions
- Male Pattern Hair Loss, Androgenetic Alopecia
- Being tested
- Bimatoprost, Placebo
- Keywords
- male pattern hair loss, androgenetic alopecia, bimatoprost
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimatoprostDrug
Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Active drug | Active comparator | 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. Receives: Drug: Bimatoprost; Drug: Placebo |
| Placebo | Active comparator | 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. Receives: Drug: Bimatoprost; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Target Area Total Hair Count
The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.
Measured: Baseline to week 17; and week 17 to week 34
Secondary outcomes (3)
Percent Change in the Target Area Terminal Hair Count
Terminal hairs are those which grow beyond a cm and contribute to overall hair density.
Measured: Baseline to week 17; and week 17 to week 34
Percent Change in the Target Area Vellus Hair Count
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
Measured: Baseline to week 17; and week 17 to week 34
Percent Change in Hair Diameter
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.
Measured: Baseline to week 17; Week 17 to week 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startNov 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Male Pattern Hair LossStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise Olsen, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170662
- Sponsor's protocol ID
- Pro00017573
- Status last verified
- Jul 2014
- First submitted
- 20 Jun 2014
- Last updated
- 5 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
- ClinicalTrials.gov ID
- NCT02170662
- Acronym / sponsor ID
- Pro00017573
- Conditions
- Male Pattern Hair Loss, Androgenetic Alopecia
- Keywords
- male pattern hair loss, androgenetic alopecia, bimatoprost
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 20 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active drug | Active comparator | Drug: Bimatoprost, Drug: PlaceboDuring 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. |
| Placebo | Active comparator | Drug: Bimatoprost, Drug: PlaceboDuring 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| BimatoprostBimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug. | Drug | Active drug, Placebo |
| Placebo | Drug | Active drug, Placebo |
Primary outcome
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.
3 secondary outcomes
Percent Change in the Target Area Terminal Hair Count
Time frame: 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
Percent Change in Hair Diameter
Time frame: Baseline to week 17; Week 17 to week 34
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elise Olsen, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bimatoprost in people with Male Pattern Hair Loss and Androgenetic Alopecia, run by Duke University.
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 10 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 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 20 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Target Area Total Hair Count (time frame: Baseline to week 17; and week 17 to week 34). 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 5 Sep 2014.