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CompletedNCT01325337Updated Apr 10, 2014Results posted

Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia

A Phase 2 interventional study of bimatoprost Formulation A and bimatoprost Formulation B in Alopecia, Alopecia, Androgenetic and Baldness, sponsored by Allergan. Completed at 2 sites in 2 countries. Open to male participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2014-04-10.

Sponsored by Allergan · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
307
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Alopecia
  • Alopecia, Androgenetic
  • Baldness
03

In context

Alopecia

607 studies on the registry are indexed under Alopecia; 129 are open to participants now.

This study's enrollment of 307 is above the median of 45 across 512 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
307 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • Drugbimatoprost Formulation A

    Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

  • Drugbimatoprost Formulation B

    Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

  • Drugbimatoprost Formulation C

    Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

  • Drugbimatoprost vehicle solution

    Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

  • Drugminoxidil 5% solution

    Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

    Also known as: Rogaine®, Regaine®

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline, Month 6

  2. 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.

    Time frame: Baseline, Month 6

Secondary outcomes

  1. 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.

    Time frame: Baseline, Month 6

  2. 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.

    Time frame: Baseline, Month 6

  3. 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).

    Time frame: Baseline, Month 6

  4. 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).

    Time frame: Baseline, Month 6

07

Results

Posted Apr 10, 2014

Participant flow

Participant flow — Overall Study
MilestoneBimatoprost Formulation ABimatoprost Formulation BBimatoprost Formulation CVehicle to BimatoprostMinoxidil 5% Solution
Started6161626261
Completed5652535253
Not completed599108
Withdrew: Adverse event02212
Withdrew: Lost to follow-up22212
Withdrew: Personal reasons25483
Withdrew: Withdrawal by subject10101

Outcome measures

PrimaryChange 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).

Time frame:
Baseline, Month 6
Reported as:
Mean · terminal hairs/cm^2
Change From Baseline in Target Area Hair Count (TAHC)
terminal hairs/cm^2Bimatoprost Formulation ABimatoprost Formulation BBimatoprost Formulation CVehicle to BimatoprostMinoxidil 5% Solution
Baseline135.0 ± 58.80145.7 ± 57.25151.5 ± 60.40143.7 ± 55.42132.7 ± 53.14
Change from Baseline at Month 613.1 ± 21.696.1 ± 19.806.3 ± 22.054.1 ± 15.5921.9 ± 19.30
PrimaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · Percentage of participants
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Percentage of participantsBimatoprost Formulation ABimatoprost Formulation BBimatoprost Formulation CVehicle to BimatoprostMinoxidil 5% Solution
Greatly Increased0.01.70.01.75.2
Moderately Increased8.611.911.76.927.6
Slightly Increased31.023.716.719.034.5
Remained the Same43.140.741.751.722.4
Slightly Decreased13.815.320.019.08.6
Moderately Decreased3.45.16.71.71.7
Greatly Decreased0.01.73.30.00.0
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · Percentage of participants
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Percentage of participantsBimatoprost Formulation ABimatoprost Formulation BBimatoprost Formulation CVehicle to BimatoprostMinoxidil 5% Solution
Greatly Increased0.05.10.00.08.6
Moderately Increased12.16.84.96.924.1
Slightly Increased29.328.823.025.915.5
Remained the Same48.355.963.963.844.8
Slightly Decreased10.33.48.23.46.9
Moderately Decreased0.00.00.00.00.0
Greatly Decreased0.00.00.00.00.0
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · Percentage of participants
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Percentage of participantsBimatoprost Formulation ABimatoprost Formulation BBimatoprost Formulation CVehicle to BimatoprostMinoxidil 5% Solution
Greatly Increased0.00.00.00.00.0
Moderately Increased3.51.80.00.05.2
Slightly Increased17.510.78.68.939.7
Remained the Same71.973.274.175.050.0
Slightly Decreased7.014.317.216.13.4
Moderately Decreased0.00.00.00.01.7
Greatly Decreased0.00.00.00.00.0
SecondaryChange 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).

Time frame:
Baseline, Month 6
Reported as:
Mean · mm/cm^2
Change From Baseline in Target Area Hair Width (TAHW)
mm/cm^2Bimatoprost Formulation ABimatoprost Formulation BBimatoprost Formulation CVehicle to BimatoprostMinoxidil 5% Solution
Baseline7.83 ± 3.8798.34 ± 3.7168.59 ± 3.6688.35 ± 3.4947.82 ± 3.436
Change from Baseline at Month 60.76 ± 1.3900.25 ± 1.1850.12 ± 1.2280.13 ± 0.8391.29 ± 1.117
SecondaryChange 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).

Time frame:
Baseline, Month 6
Reported as:
Mean · Intensity units
Change From Baseline in Target Area Hair Darkness (TAHD)
Intensity unitsBimatoprost Formulation ABimatoprost Formulation BBimatoprost Formulation CVehicle to BimatoprostMinoxidil 5% Solution
Baseline106.88 ± 19.282103.85 ± 21.950100.81 ± 18.041104.03 ± 17.86399.57 ± 28.139
Change from Baseline at Month 61.19 ± 12.0002.92 ± 14.6864.04 ± 11.0610.65 ± 10.6263.40 ± 12.888

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bimatoprost Formulation A—0/61 (0%)6/61 (9.8%)
Bimatoprost Formulation B—1/61 (1.6%)11/61 (18%)
Bimatoprost Formulation C—1/62 (1.6%)4/62 (6.5%)
Vehicle to Bimatoprost—1/62 (1.6%)7/62 (11.3%)
Minoxidil 5% Solution—0/61 (0%)10/61 (16.4%)
Most frequent serious events
Most frequent serious events
EventBimatoprost Formulation ABimatoprost Formulation BBimatoprost Formulation CVehicle to BimatoprostMinoxidil 5% Solution
Back painMusculoskeletal and connective tissue disorders0/611/610/620/620/61
Femur fractureInjury, poisoning and procedural complications0/610/611/620/620/61
Humerus fractureInjury, poisoning and procedural complications0/610/611/620/620/61
Radius fractureInjury, poisoning and procedural complications0/610/611/620/620/61
Tibia fractureInjury, poisoning and procedural complications0/610/611/620/620/61
Wrist fractureInjury, poisoning and procedural complications0/610/611/620/620/61
OsteonecrosisMusculoskeletal and connective tissue disorders0/610/610/621/620/61
Most frequent other events
Most frequent other events
EventBimatoprost Formulation ABimatoprost Formulation BBimatoprost Formulation CVehicle to BimatoprostMinoxidil 5% Solution
NasopharyngitisInfections and infestations5/617/614/627/623/61
Application site pruritisGeneral disorders1/614/610/620/627/61

Baseline characteristics

Age, Customized
Age, Customized(Participants)Bimatoprost Formulation ABimatoprost Formulation BBimatoprost Formulation CVehicle to BimatoprostMinoxidil 5% SolutionTotal
18 to 34 years191820181893
35 to 50 years4243424443214
Sex: Female, Male
Sex: Female, Male(Participants)Bimatoprost Formulation ABimatoprost Formulation BBimatoprost Formulation CVehicle to BimatoprostMinoxidil 5% SolutionTotal
Female000000
Male6161626261307
08

Study locations

2 sites
  • Portland, Oregon, United States
  • Berlin, Germany
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01325337
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Mar 29, 2011
Start date
Jun 2011
Primary completion
Aug 2012
Completion
Sep 2012
Results posted
Apr 10, 2014
Last update
Apr 10, 2014

Study contacts

Medical Director
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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