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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
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief 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.

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 Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: bimatoprost Formulation A
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
 Drug: bimatoprost Formulation A
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
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.
 Drug: bimatoprost Formulation C
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Placebo Comparator: bimatoprost vehicle solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
 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.
 Drug: minoxidil 5% solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Other Names:
  • Rogaine®
  • Regaine®


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Oregon
Portland, Oregon, United States
Germany
Berlin, Germany
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
More Information
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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