AlopeciaPhase 2NCT01904721

A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)

A Phase 2 study testing Bimatoprost Solution 1 and Bimatoprost Solution 2 in people with Alopecia and Alopecia, Androgenetic, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA). Read more about this study

Who is it for?: Ages 18 to 49 years, men only
Conditions the study is for: Alopecia, Alopecia, Androgenetic, Baldness
What is being tested?: Bimatoprost Solution 1 and Bimatoprost Solution 2
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 244 participants
Where: 1 siteUnited States
Study dates: Aug 2013to Jan 2015
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 49 years
Men only
No healthy volunteers
Adult

Who may be able to join

Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
Willingness to maintain same hair style, length and hair color during study
Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only)

Who cannot join

Drug or alcohol abuse within 12 months
HIV positive
Received hair transplants or had scalp reductions
Use of hair weaves, hair extensions or wigs within 3 months
Use of minoxidil (oral or topical) and/or low level light treatment "combs" for hair growth within the last 6 months, or expected use during the study
Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Fridley, Minnesota

Other trials in United States

About this study

This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).

Conditions: Alopecia, Alopecia, Androgenetic, Baldness
Being tested: Bimatoprost Solution 1, Bimatoprost Solution 2, Bimatoprost Vehicle
Medical subject headings: Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bimatoprost Solution 1Drug
Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Bimatoprost Solution 2Drug
Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Bimatoprost VehicleDrug
Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Study groups in NCT01904721
Study group	Role	What they receive
Stage 1: Bimatoprost Solution 1 Twice Daily	Experimental	Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days. Receives: Drug: Bimatoprost Solution 1
Stage 1: Bimatoprost Solution 1 Once Daily	Experimental	Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days. Receives: Drug: Bimatoprost Solution 1; Drug: Bimatoprost Vehicle
Stage 1: Bimatoprost Solution 2 Twice Daily	Experimental	Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days. Receives: Drug: Bimatoprost Solution 2
Stage 1: Bimatoprost Solution 2 Once Daily	Experimental	Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days. Receives: Drug: Bimatoprost Solution 2; Drug: Bimatoprost Vehicle
Stage 2: Bimatoprost Solution 1 Twice Daily	Experimental	Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months. Receives: Drug: Bimatoprost Solution 1
Stage 2: Bimatoprost Solution 2 Twice Daily	Experimental	Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months. Receives: Drug: Bimatoprost Solution 2
Stage 2: Bimatoprost Vehicle Twice Daily	Placebo comparator	Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months. Receives: Drug: Bimatoprost Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Target Area Hair Count (TAHC)
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).
Measured: Baseline, Month 6
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Measured: Month 6

Secondary outcomes (4)

Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Measured: Month 6
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Measured: Month 6
Change From Baseline in Target Area Hair Width (TAHW)
Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).
Measured: Baseline, Month 6
Change From Baseline in Target Area Hair Darkness (TAHD)
Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs).
Measured: Baseline, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Jan 2015

First posted22 Jul 2013 (estimated)
Study startAug 2013
Primary completionSep 2014
Study completionJan 2015

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 AlopeciaStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 244 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01904721
Sponsor's protocol ID: 192024-084
Status last verified: Feb 2016
First submitted: 18 Jul 2013
Last updated: 22 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alopecia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
ClinicalTrials.gov ID: NCT01904721
Acronym / sponsor ID: 192024-084
Conditions: Alopecia, Alopecia, Androgenetic, Baldness
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 244 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Sep 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 22 Jul 2013 (estimated)
Results: Posted 9 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 7

Arm	Type	Receives
Stage 1: Bimatoprost Solution 1 Twice Daily	Experimental	Drug: Bimatoprost Solution 1Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
Stage 1: Bimatoprost Solution 1 Once Daily	Experimental	Drug: Bimatoprost Solution 1, Drug: Bimatoprost VehicleStage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
Stage 1: Bimatoprost Solution 2 Twice Daily	Experimental	Drug: Bimatoprost Solution 2Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
Stage 1: Bimatoprost Solution 2 Once Daily	Experimental	Drug: Bimatoprost Solution 2, Drug: Bimatoprost VehicleStage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
Stage 2: Bimatoprost Solution 1 Twice Daily	Experimental	Drug: Bimatoprost Solution 1Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Solution 2 Twice Daily	Experimental	Drug: Bimatoprost Solution 2Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Vehicle Twice Daily	Placebo comparator	Drug: Bimatoprost VehicleStage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.

Who may qualify

Ages: 18 to 49 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
Willingness to maintain same hair style, length and hair color during study
Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only)

Key exclusion criteria (6 listed)

Drug or alcohol abuse within 12 months
HIV positive
Received hair transplants or had scalp reductions
Use of hair weaves, hair extensions or wigs within 3 months
Use of minoxidil (oral or topical) and/or low level light treatment "combs" for hair growth within the last 6 months, or expected use during the study

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
Bimatoprost Solution 1Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.	Drug	Stage 1: Bimatoprost Solution 1 Once Daily, Stage 1: Bimatoprost Solution 1 Twice Daily, Stage 2: Bimatoprost Solution 1 Twice Daily
Bimatoprost Solution 2Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.	Drug	Stage 1: Bimatoprost Solution 2 Once Daily, Stage 1: Bimatoprost Solution 2 Twice Daily, Stage 2: Bimatoprost Solution 2 Twice Daily
Bimatoprost VehicleBimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.	Drug	Stage 1: Bimatoprost Solution 1 Once Daily, Stage 1: Bimatoprost Solution 2 Once Daily, Stage 2: Bimatoprost Vehicle Twice Daily

Primary outcome

Change From Baseline in Target Area Hair Count (TAHC)
Time frame: Baseline, Month 6
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Time frame: Month 6
The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

4 secondary outcomes

Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Time frame: Month 6
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Time frame: Month 6
Change From Baseline in Target Area Hair Width (TAHW)
Time frame: Baseline, Month 6
Change From Baseline in Target Area Hair Darkness (TAHD)
Time frame: Baseline, Month 6

Results and safety

Results posted to the registry on 9 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1: Bimatoprost Solution 1 Twice Daily	13	13
Stage 1: Bimatoprost Solution 1 Once Daily	13	13
Stage 1: Bimatoprost Solution 2 Twice Daily	12	11
Stage 1: Bimatoprost Solution 2 Once Daily	12	11
Stage 2: Bimatoprost Solution 1 Twice Daily	65	57
Stage 2: Bimatoprost Solution 2 Twice Daily	65	56
Stage 2: Bimatoprost Vehicle Twice Daily	64	57

Primary outcome: Change From Baseline in Target Area Hair Count (TAHC)

Time frame: Baseline, Month 6. Mean (Standard Deviation). Unit: terminal hairs/cm2

Measure	Stage 2: Bimatoprost Solution 2 Twice Daily n = 63	Stage 2: Bimatoprost Solution 1 Twice Daily n = 62	Stage 2: Bimatoprost Vehicle Twice Daily n = 60
Baseline	131.3 (55.53)	140.4 (59.76)	129.0 (57.42)
Change from Baseline at Month 6	9.3 (23.09)	12.7 (26.39)	5.8 (20.95)

Population analysed: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements

Primary outcome: Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score

Time frame: Month 6. Number. Unit: Percentage of Participants

Measure	Stage 2: Bimatoprost Solution 2 Twice Daily n = 63	Stage 2: Bimatoprost Solution 1 Twice Daily n = 62	Stage 2: Bimatoprost Vehicle Twice Daily n = 60
Greatly increased	4.8	6.5	0.0
Moderately increased	25.4	14.5	6.7
Slightly increased	33.3	33.9	20.0
Remained the same	23.8	30.6	35.0
Slightly decreased	12.7	12.9	30.0
Moderately decreased	0.0	1.6	6.7
Greatly decreased	0.0	0.0	1.7

Population analysed: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1: Bimatoprost Solution 1 Twice Daily	0 of 13 (0%)	5 of 13 (38.5%)	Not reported
Stage 1: Bimatoprost Solution 1 Once Daily	0 of 13 (0%)	4 of 13 (30.8%)	Not reported
Stage 1: Bimatoprost Solution 2 Twice Daily	0 of 12 (0%)	7 of 12 (58.3%)	Not reported
Stage 1: Bimatoprost Solution 2 Once Daily	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
Stage 2: Bimatoprost Solution 2 Twice Daily	1 of 65 (1.5%)	25 of 65 (38.5%)	Not reported
Stage 2: Bimatoprost Solution 1 Twice Daily	2 of 65 (3.1%)	25 of 65 (38.5%)	Not reported
Stage 2: Bimatoprost Vehicle Twice Daily	0 of 64 (0%)	7 of 64 (10.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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.

Medical Director study director

Allergan

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 Bimatoprost Solution 1 and Bimatoprost Solution 2 in people with Alopecia and Alopecia, Androgenetic, run by Allergan 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 3 inclusion and 6 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 22 Mar 2016. 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. Some participants in this study may receive a placebo. 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 9 Dec 2015). 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?

Change From Baseline in Target Area Hair Count (TAHC) (time frame: Baseline, Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01904721.

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 22 Mar 2016.