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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alopecia
Alopecia, Androgenetic
Baldness
Interventions Drug: bimatoprost Formulation A
Drug: bimatoprost Formulation B
Drug: bimatoprost Formulation C
Drug: bimatoprost vehicle solution
Drug: minoxidil 5% solution
Enrollment 307
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bimatoprost Formulation A Bimatoprost Formulation B Bimatoprost Formulation C Vehicle to Bimatoprost Minoxidil 5% Solution
Hide Arm/Group Description Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months. Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months. Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months. Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Period Title: Overall Study
Started 61 61 62 62 61
Completed 56 52 53 52 53
Not Completed 5 9 9 10 8
Reason Not Completed
Adverse Event             0             2             2             1             2
Lost to Follow-up             2             2             2             1             2
Personal Reasons             2             5             4             8             3
Withdrawal by Subject             1             0             1             0             1
Arm/Group Title Bimatoprost Formulation A Bimatoprost Formulation B Bimatoprost Formulation C Vehicle to Bimatoprost Minoxidil 5% Solution Total
Hide Arm/Group Description Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months. Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months. Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months. Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months. Total of all reporting groups
Overall Number of Baseline Participants 61 61 62 62 61 307
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 62 participants 62 participants 61 participants 307 participants
18 to 34 years 19 18 20 18 18 93
35 to 50 years 42 43 42 44 43 214
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 62 participants 62 participants 61 participants 307 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
61
 100.0%
61
 100.0%
62
 100.0%
62
 100.0%
61
 100.0%
307
 100.0%
1.Primary Outcome
Title Change From Baseline in Target Area Hair Count (TAHC)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.
Arm/Group Title Bimatoprost Formulation A Bimatoprost Formulation B Bimatoprost Formulation C Vehicle to Bimatoprost Minoxidil 5% Solution
Hide Arm/Group Description:
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Overall Number of Participants Analyzed 60 61 61 61 61
Mean (Standard Deviation)
Unit of Measure: terminal hairs/cm^2
Baseline 135.0  (58.80) 145.7  (57.25) 151.5  (60.40) 143.7  (55.42) 132.7  (53.14)
Change from Baseline at Month 6 13.1  (21.69) 6.1  (19.80) 6.3  (22.05) 4.1  (15.59) 21.9  (19.30)
2.Primary Outcome
Title Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.
Arm/Group Title Bimatoprost Formulation A Bimatoprost Formulation B Bimatoprost Formulation C Vehicle to Bimatoprost Minoxidil 5% Solution
Hide Arm/Group Description:
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Overall Number of Participants Analyzed 58 59 60 58 58
Measure Type: Number
Unit of Measure: Percentage of participants
Greatly Increased 0.0 1.7 0.0 1.7 5.2
Moderately Increased 8.6 11.9 11.7 6.9 27.6
Slightly Increased 31.0 23.7 16.7 19.0 34.5
Remained the Same 43.1 40.7 41.7 51.7 22.4
Slightly Decreased 13.8 15.3 20.0 19.0 8.6
Moderately Decreased 3.4 5.1 6.7 1.7 1.7
Greatly Decreased 0.0 1.7 3.3 0.0 0.0
3.Secondary Outcome
Title Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.
Arm/Group Title Bimatoprost Formulation A Bimatoprost Formulation B Bimatoprost Formulation C Vehicle to Bimatoprost Minoxidil 5% Solution
Hide Arm/Group Description:
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Overall Number of Participants Analyzed 58 59 61 58 58
Measure Type: Number
Unit of Measure: Percentage of participants
Greatly Increased 0.0 5.1 0.0 0.0 8.6
Moderately Increased 12.1 6.8 4.9 6.9 24.1
Slightly Increased 29.3 28.8 23.0 25.9 15.5
Remained the Same 48.3 55.9 63.9 63.8 44.8
Slightly Decreased 10.3 3.4 8.2 3.4 6.9
Moderately Decreased 0.0 0.0 0.0 0.0 0.0
Greatly Decreased 0.0 0.0 0.0 0.0 0.0
4.Secondary Outcome
Title Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.
Arm/Group Title Bimatoprost Formulation A Bimatoprost Formulation B Bimatoprost Formulation C Vehicle to Bimatoprost Minoxidil 5% Solution
Hide Arm/Group Description:
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Overall Number of Participants Analyzed 57 56 58 56 58
Measure Type: Number
Unit of Measure: Percentage of participants
Greatly Increased 0.0 0.0 0.0 0.0 0.0
Moderately Increased 3.5 1.8 0.0 0.0 5.2
Slightly Increased 17.5 10.7 8.6 8.9 39.7
Remained the Same 71.9 73.2 74.1 75.0 50.0
Slightly Decreased 7.0 14.3 17.2 16.1 3.4
Moderately Decreased 0.0 0.0 0.0 0.0 1.7
Greatly Decreased 0.0 0.0 0.0 0.0 0.0
5.Secondary Outcome
Title Change From Baseline in Target Area Hair Width (TAHW)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.
Arm/Group Title Bimatoprost Formulation A Bimatoprost Formulation B Bimatoprost Formulation C Vehicle to Bimatoprost Minoxidil 5% Solution
Hide Arm/Group Description:
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Overall Number of Participants Analyzed 60 61 61 61 61
Mean (Standard Deviation)
Unit of Measure: mm/cm^2
Baseline 7.83  (3.879) 8.34  (3.716) 8.59  (3.668) 8.35  (3.494) 7.82  (3.436)
Change from Baseline at Month 6 0.76  (1.390) 0.25  (1.185) 0.12  (1.228) 0.13  (0.839) 1.29  (1.117)
6.Secondary Outcome
Title Change From Baseline in Target Area Hair Darkness (TAHD)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.
Arm/Group Title Bimatoprost Formulation A Bimatoprost Formulation B Bimatoprost Formulation C Vehicle to Bimatoprost Minoxidil 5% Solution
Hide Arm/Group Description:
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Overall Number of Participants Analyzed 60 61 61 61 61
Mean (Standard Deviation)
Unit of Measure: Intensity units
Baseline 106.88  (19.282) 103.85  (21.950) 100.81  (18.041) 104.03  (17.863) 99.57  (28.139)
Change from Baseline at Month 6 1.19  (12.000) 2.92  (14.686) 4.04  (11.061) 0.65  (10.626) 3.40  (12.888)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Population, that consisted of all participants who received at least 1 dose of study treatment, was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
 
Arm/Group Title Bimatoprost Formulation A Bimatoprost Formulation B Bimatoprost Formulation C Vehicle to Bimatoprost Minoxidil 5% Solution
Hide Arm/Group Description Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months. Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months. Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months. Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
All-Cause Mortality
Bimatoprost Formulation A Bimatoprost Formulation B Bimatoprost Formulation C Vehicle to Bimatoprost Minoxidil 5% Solution
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bimatoprost Formulation A Bimatoprost Formulation B Bimatoprost Formulation C Vehicle to Bimatoprost Minoxidil 5% Solution
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   1/61 (1.64%)   1/62 (1.61%)   1/62 (1.61%)   0/61 (0.00%) 
Injury, poisoning and procedural complications           
Femur fracture  1 [1]  0/61 (0.00%)  0/61 (0.00%)  1/62 (1.61%)  0/62 (0.00%)  0/61 (0.00%) 
Humerus fracture  1 [1]  0/61 (0.00%)  0/61 (0.00%)  1/62 (1.61%)  0/62 (0.00%)  0/61 (0.00%) 
Radius fracture  1 [1]  0/61 (0.00%)  0/61 (0.00%)  1/62 (1.61%)  0/62 (0.00%)  0/61 (0.00%) 
Tibia fracture  1 [1]  0/61 (0.00%)  0/61 (0.00%)  1/62 (1.61%)  0/62 (0.00%)  0/61 (0.00%) 
Wrist fracture  1 [1]  0/61 (0.00%)  0/61 (0.00%)  1/62 (1.61%)  0/62 (0.00%)  0/61 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain * 1 [1]  0/61 (0.00%)  1/61 (1.64%)  0/62 (0.00%)  0/62 (0.00%)  0/61 (0.00%) 
Osteonecrosis  1 [1]  0/61 (0.00%)  0/61 (0.00%)  0/62 (0.00%)  1/62 (1.61%)  0/61 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.0)
[1]
Event not treatment-related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bimatoprost Formulation A Bimatoprost Formulation B Bimatoprost Formulation C Vehicle to Bimatoprost Minoxidil 5% Solution
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/61 (9.84%)   11/61 (18.03%)   4/62 (6.45%)   7/62 (11.29%)   10/61 (16.39%) 
General disorders           
Application site pruritis * 1  1/61 (1.64%)  4/61 (6.56%)  0/62 (0.00%)  0/62 (0.00%)  7/61 (11.48%) 
Infections and infestations           
Nasopharyngitis  1  5/61 (8.20%)  7/61 (11.48%)  4/62 (6.45%)  7/62 (11.29%)  3/61 (4.92%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01325337     History of Changes
Other Study ID Numbers: 192024-057
2011-000379-15 ( EudraCT Number )
First Submitted: March 28, 2011
First Posted: March 29, 2011
Results First Submitted: March 3, 2014
Results First Posted: April 10, 2014
Last Update Posted: April 10, 2014