Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
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ClinicalTrials.gov Identifier: NCT01325337 |
Recruitment Status
:
Completed
First Posted
: March 29, 2011
Results First Posted
: April 10, 2014
Last Update Posted
: April 10, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alopecia Alopecia, Androgenetic Baldness | Drug: bimatoprost Formulation A Drug: bimatoprost Formulation B Drug: bimatoprost Formulation C Drug: bimatoprost vehicle solution Drug: minoxidil 5% solution | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 307 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: bimatoprost Formulation A
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
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Drug: bimatoprost Formulation A
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
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Experimental: bimatoprost Formulation B
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Drug: bimatoprost Formulation B
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Experimental: bimatoprost Formulation C
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
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Drug: bimatoprost Formulation C
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
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Placebo Comparator: bimatoprost vehicle solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
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Drug: bimatoprost vehicle solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Active Comparator: minoxidil 5% solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
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Drug: minoxidil 5% solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Other Names:
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- 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.
- Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score [ Time Frame: Baseline, 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.
- Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score [ Time Frame: Baseline, 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.
- 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).
- 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).

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Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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
- Oral or topical minoxidil treatment within 6 months
- Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325337
United States, Oregon | |
Portland, Oregon, United States | |
Germany | |
Berlin, Germany |
Study Director: | Medical Director | Allergan |
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT01325337 History of Changes |
Other Study ID Numbers: |
192024-057 2011-000379-15 ( EudraCT Number ) |
First Posted: | March 29, 2011 Key Record Dates |
Results First Posted: | April 10, 2014 |
Last Update Posted: | April 10, 2014 |
Last Verified: | April 2014 |
Additional relevant MeSH terms:
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical |
Pharmaceutical Solutions Bimatoprost Minoxidil Antihypertensive Agents Vasodilator Agents |