- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01904721
A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
February 23, 2016 updated by: Allergan
This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
244
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Fridley, Minnesota, United States
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Stage 1: Bimatoprost Solution 1 Twice Daily
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
|
Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
|
EXPERIMENTAL: Stage 1: Bimatoprost Solution 1 Once Daily
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
|
Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
|
EXPERIMENTAL: Stage 1: Bimatoprost Solution 2 Twice Daily
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
|
Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
|
EXPERIMENTAL: Stage 1: Bimatoprost Solution 2 Once Daily
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
|
Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
|
EXPERIMENTAL: Stage 2: Bimatoprost Solution 1 Twice Daily
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
|
EXPERIMENTAL: Stage 2: Bimatoprost Solution 2 Twice Daily
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
|
PLACEBO_COMPARATOR: Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline, Month 6
|
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.
|
Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Time Frame: Month 6
|
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.
|
Month 6
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Time Frame: Month 6
|
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.
|
Month 6
|
Change From Baseline in Target Area Hair Width (TAHW)
Time Frame: Baseline, Month 6
|
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).
|
Baseline, Month 6
|
Change From Baseline in Target Area Hair Darkness (TAHD)
Time Frame: Baseline, Month 6
|
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).
|
Baseline, Month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (ACTUAL)
September 1, 2014
Study Completion (ACTUAL)
January 1, 2015
Study Registration Dates
First Submitted
July 18, 2013
First Submitted That Met QC Criteria
July 18, 2013
First Posted (ESTIMATE)
July 22, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
March 22, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 192024-084
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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