AlopeciaPhase 2NCT01325337
Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
A Phase 2 study testing bimatoprost Formulation A, bimatoprost Formulation B and bimatoprost Formulation C in people with Alopecia and Alopecia, Androgenetic, run by Allergan at 2 sites in 2 countries.
Trial summary
This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label. 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 Formulation A, bimatoprost Formulation B and bimatoprost Formulation C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 307 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2011to Sep 2012
- 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 have micro-dot-tattoo applied to scalp
- Willingness to maintain same hair style, length and hair color during study
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
- Oral or topical minoxidil treatment within 6 months
- Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.
- Conditions
- Alopecia, Alopecia, Androgenetic, Baldness
- Being tested
- bimatoprost Formulation A, bimatoprost Formulation B, bimatoprost Formulation C, bimatoprost vehicle solution, minoxidil 5% solution
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost Formulation ADrug
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
bimatoprost Formulation BDrug
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
bimatoprost Formulation CDrug
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
bimatoprost vehicle solutionDrug
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
minoxidil 5% solutionDrug
Also called Rogaine®, Regaine®
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| bimatoprost Formulation A | Experimental | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. Receives: Drug: bimatoprost Formulation A |
| bimatoprost Formulation B | Experimental | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. Receives: Drug: bimatoprost Formulation B |
| bimatoprost Formulation C | Experimental | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. Receives: Drug: bimatoprost Formulation C |
| bimatoprost vehicle solution | Placebo comparator | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. Receives: Drug: bimatoprost vehicle solution |
| minoxidil 5% solution | Active comparator | Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months. Receives: Drug: minoxidil 5% solution |
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).
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: Baseline, 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: Baseline, 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: Baseline, 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).
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).
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.
- First posted29 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2012
- Study completionSep 2012
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, Investigator, Outcomes assessor
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325337
- Sponsor's protocol ID
- 192024-057
- Other IDs
- 2011-000379-15
- Status last verified
- Apr 2014
- First submitted
- 28 Mar 2011
- Last updated
- 10 Apr 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 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
- ClinicalTrials.gov ID
- NCT01325337
- Acronym / sponsor ID
- 192024-057
- Conditions
- Alopecia, Alopecia, Androgenetic, Baldness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Posted 10 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| bimatoprost Formulation A | Experimental | Drug: bimatoprost Formulation AApproximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| bimatoprost Formulation B | Experimental | Drug: bimatoprost Formulation BApproximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| bimatoprost Formulation C | Experimental | Drug: bimatoprost Formulation CApproximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| bimatoprost vehicle solution | Placebo comparator | Drug: bimatoprost vehicle solutionApproximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| minoxidil 5% solution | Active comparator | Drug: minoxidil 5% solutionApproximately one mL dose applied evenly onto pre-specified area on 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 have micro-dot-tattoo applied to scalp
- Willingness to maintain same hair style, length and hair color during study
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
- Oral or topical minoxidil treatment within 6 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 |
|---|---|---|
| bimatoprost Formulation AApproximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. | Drug | bimatoprost Formulation A |
| bimatoprost Formulation BApproximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. | Drug | bimatoprost Formulation B |
| bimatoprost Formulation CApproximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. | Drug | bimatoprost Formulation C |
| bimatoprost vehicle solutionApproximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. | Drug | bimatoprost vehicle solution |
| minoxidil 5% solutionAlso: Rogaine®, Regaine®Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months. | Drug | minoxidil 5% solution |
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).
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Time frame: Baseline, 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: Baseline, Month 6
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Time frame: Baseline, 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 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.
Medical Director study director
Allergan
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bimatoprost Formulation A, bimatoprost Formulation B and bimatoprost Formulation C in people with Alopecia and Alopecia, Androgenetic, run by Allergan at 2 sites in 2 countries.
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 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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 10 Apr 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?
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?
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 10 Apr 2014.