A Safety and Efficacy Study of Bimatoprost in Men With An... | NCT01904721 | Trialant
NCT01904721
Sponsor
Allergan
Status
Completed
Last Update Posted
Mar 22, 2016Estimated
Enrollment
244Actual
Phase
Phase 2
Conditions
Alopecia
Alopecia, Androgenetic
Baldness
Interventions
Bimatoprost Solution 1
Bimatoprost Solution 2
Bimatoprost Vehicle
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01904721
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
192024-084
Secondary IDs
Not provided
Brief Title
A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
Official Title
Not provided
Acronym
Not provided
Organization
AllerganINDUSTRY
Status Module
Record Verification Date
Feb 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2013
Primary Completion Date
Sep 2014Actual
Completion Date
Jan 2015Actual
First Submitted Date
Jul 18, 2013
First Submission Date that Met QC Criteria
Jul 18, 2013
First Posted Date
Jul 22, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 4, 2015
Results First Submitted that Met QC Criteria
Nov 4, 2015
Results First Posted Date
Dec 9, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 23, 2016
Last Update Posted Date
Mar 22, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AllerganINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).
Detailed Description
Not provided
Conditions Module
Conditions
Alopecia
Alopecia, Androgenetic
Baldness
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
244Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1: Bimatoprost Solution 1 Twice Daily
Experimental
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
Drug: Bimatoprost Solution 1
Stage 1: Bimatoprost Solution 1 Once Daily
Experimental
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost Solution 1
Drug: Bimatoprost Vehicle
Stage 1: Bimatoprost Solution 2 Twice Daily
Experimental
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
Drug: Bimatoprost Solution 2
Stage 1: Bimatoprost Solution 2 Once Daily
Experimental
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost Solution 2
Drug: Bimatoprost Vehicle
Stage 2: Bimatoprost Solution 1 Twice Daily
Experimental
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Bimatoprost Solution 1
Drug
Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Stage 1: Bimatoprost Solution 1 Once Daily
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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) 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
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 Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
49 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Allergan
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Fridley
Minnesota
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
FG001
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.
FG002
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.
FG003
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.
FG004
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.
FG005
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.
FG006
Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00013 subjects
FG00113 subjects
FG00212 subjects
FG00312 subjects
FG00465 subjects
FG00565 subjects
FG00664 subjects
COMPLETED
FG00013 subjects
FG00113 subjects
FG00211 subjects
FG00311 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Other Reasons
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
Stage 1: Bimatoprost Solution 1 Once Daily
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).
Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Posted
Mean
Standard Deviation
terminal hairs/cm2
Baseline, Month 6
ID
Title
Description
OG000
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.
OG001
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Coronary Artery Occlusion
Cardiac disorders
MedDRA version 17.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrioventricular Block First Degree
Cardiac disorders
MedDRA version 17.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Therapeutic Area Head,
Allergan, Inc
714-246-4500
clinicaltrials@allergan.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D000505
Alopecia
Ancestor Terms
ID
Term
D007039
Hypotrichosis
D006201
Hair Diseases
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D000069580
Bimatoprost
Ancestor Terms
ID
Term
D000577
Amides
D009930
Organic Chemicals
D003008
Cloprostenol
D011461
Prostaglandins F, Synthetic
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Drug: Bimatoprost Solution 1
Stage 2: Bimatoprost Solution 2 Twice Daily
Experimental
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Drug: Bimatoprost Solution 2
Stage 2: Bimatoprost Vehicle Twice Daily
Placebo Comparator
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Drug: Bimatoprost Vehicle
Stage 1: Bimatoprost Solution 1 Twice Daily
Stage 2: Bimatoprost Solution 1 Twice Daily
Bimatoprost Solution 2
Drug
Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Stage 1: Bimatoprost Solution 2 Once Daily
Stage 1: Bimatoprost Solution 2 Twice Daily
Stage 2: Bimatoprost Solution 2 Twice Daily
Bimatoprost Vehicle
Drug
Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Stage 1: Bimatoprost Solution 1 Once Daily
Stage 1: Bimatoprost Solution 2 Once Daily
Stage 2: Bimatoprost Vehicle Twice Daily
Month 6
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.
Month 6
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) 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)
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
57 subjects
FG00556 subjects
FG00657 subjects
8 subjects
FG0059 subjects
FG0067 subjects
1 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
Personal Reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0053 subjects
FG0063 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0053 subjects
FG0061 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0051 subjects
FG0060 subjects
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
BG007
Total
Total of all reporting groups
13
BG00113
BG00212
BG00312
BG00465
BG00565
BG00664
BG007244
Participants
Title
Denominators
Categories
≥18 to <35 years
Title
Measurements
BG0008
BG0010
BG0023
BG0033
BG00417
BG00518
BG00617
BG00766
35 to 49 years
Title
Measurements
BG0005
BG00113
BG0029
BG003
Sex/Gender, Customized
Number
Participants
Title
Denominators
Categories
Male
Title
Measurements
BG00013
BG00113
BG00212
BG00312
BG00465
BG00565
BG00664
BG007244
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.
OG002
Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Units
Counts
Participants
OG00063
OG00162
OG00260
Title
Denominators
Categories
Baseline
Title
Measurements
OG000131.3± 55.53
OG001140.4± 59.76
OG002129.0± 57.42
Change from Baseline at Month 6
Title
Measurements
OG0009.3± 23.09
OG00112.7± 26.39
OG0025.8± 20.95
Primary
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.
Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Posted
Number
Percentage of Participants
Month 6
ID
Title
Description
OG000
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.
OG001
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.
OG002
Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Units
Counts
Participants
OG00063
OG00162
OG00260
Title
Denominators
Categories
Greatly increased
Title
Measurements
OG0004.8
OG0016.5
OG0020.0
Moderately increased
Secondary
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.
Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Posted
Number
Percentage of Participants
Month 6
ID
Title
Description
OG000
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.
OG001
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.
OG002
Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Units
Counts
Participants
OG00063
OG00162
OG00260
Title
Denominators
Categories
Greatly increased
Title
Measurements
OG0004.8
OG00111.3
OG0020.0
Moderately increased
Secondary
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.
Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Posted
Number
Percentage of Participants
Month 6
ID
Title
Description
OG000
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.
OG001
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.
OG002
Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Units
Counts
Participants
OG00062
OG00160
OG00258
Title
Denominators
Categories
Greatly increased
Title
Measurements
OG0001.6
OG0013.3
OG0020.0
Moderately increased
Secondary
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) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).
Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Posted
Mean
Standard Deviation
mm/cm2
Baseline, Month 6
ID
Title
Description
OG000
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.
OG001
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.
OG002
Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Units
Counts
Participants
OG00063
OG00162
OG00260
Title
Denominators
Categories
Baseline
Title
Measurements
OG0007.32± 3.472
OG0017.82± 3.764
OG0027.30± 3.550
Change from Baseline at Month 6
Secondary
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) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs).
Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Posted
Mean
Standard Deviation
Intensity Units
Baseline, Month 6
ID
Title
Description
OG000
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.
OG001
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.
OG002
Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Units
Counts
Participants
OG00063
OG00162
OG00260
Title
Denominators
Categories
Baseline
Title
Measurements
OG000113.77± 19.458
OG001115.76± 20.014
OG002115.22± 19.879
Change from Baseline at Month 6
0
13
5
13
EG001
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.
0
13
4
13
EG002
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.
0
12
7
12
EG003
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.
0
12
1
12
EG004
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.
1
65
25
65
EG005
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.
2
65
25
65
EG006
Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
0
64
7
64
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0051 affected65 at risk
EG0060 affected64 at risk
Myocardial Infarction
Cardiac disorders
MedDRA version 17.1
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0051 affected65 at risk
EG0060 affected64 at risk
Clavicle Fracture
Injury, poisoning and procedural complications
MedDRA version 17.1
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0041 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0041 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Scapula Fracture
Injury, poisoning and procedural complications
MedDRA version 17.1
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0041 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA version 17.1
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0041 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
EG0000 affected13 at risk
EG0012 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0041 affected65 at risk
EG0051 affected65 at risk
EG0061 affected64 at risk
Influenza Like Illness
General disorders
MedDRA version 17.1
Non-systematic Assessment
EG0002 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Application Site Pruritus
General disorders
MedDRA version 17.1
Non-systematic Assessment
EG0001 affected13 at risk
EG0010 affected13 at risk
EG0021 affected12 at risk
EG0030 affected12 at risk
EG0041 affected65 at risk
EG0052 affected65 at risk
EG0060 affected64 at risk
Upper Respiratory Tract Infection
Infections and infestations
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0022 affected12 at risk
EG0031 affected12 at risk
EG0041 affected65 at risk
EG0052 affected65 at risk
EG0061 affected64 at risk
Electrocardiogram T Wave Amplitude Increased
Investigations
MedDRA version 17.1
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected13 at risk
EG0021 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA version 17.1
Non-systematic Assessment
EG0001 affected13 at risk
EG0010 affected13 at risk
EG0022 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0061 affected64 at risk
Headache
Nervous system disorders
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0012 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0053 affected65 at risk
EG0061 affected64 at risk
Growth of Eyelashes
Eye disorders
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG00410 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Application Site Erythema
General disorders
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0043 affected65 at risk
EG0055 affected65 at risk
EG0062 affected64 at risk
Application Site Discoloration
General disorders
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0041 affected65 at risk
EG0054 affected65 at risk
EG0061 affected64 at risk
Hair Growth Abnormal
Skin and subcutaneous tissue disorders
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0021 affected12 at risk
EG0030 affected12 at risk
EG0046 affected65 at risk
EG0052 affected65 at risk
EG0060 affected64 at risk
Hypertrichosis
Skin and subcutaneous tissue disorders
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0045 affected65 at risk
EG0056 affected65 at risk
EG0060 affected64 at risk
Blood Glucose Increased
Investigations
MedDRA version 17.1
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0061 affected64 at risk
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA version 17.1
Non-systematic Assessment
EG0001 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0041 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Glucose Urine Present
Investigations
MedDRA version 17.1
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Skin Irritation
Skin and subcutaneous tissue disorders
MedDRA version 17.1
Non-systematic Assessment
EG0001 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Atrial Fibrillation
Cardiac disorders
MedDRA version 17.1
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Bundle Branch Block Left
Cardiac disorders
MedDRA version 17.1
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0051 affected65 at risk
EG0060 affected64 at risk
Conjunctival Hyperaemia
Eye disorders
MedDRA version 17.1
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Dry Eye
Eye disorders
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0042 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected13 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Corneal Irritation
Eye disorders
MedDRA version 17.1
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0021 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Folliculitis
Infections and infestations
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0021 affected12 at risk
EG0030 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Ear Lobe Infection
Infections and infestations
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0031 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Eye Pruritus
Eye disorders
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0031 affected12 at risk
EG0041 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Joint Swelling
Musculoskeletal and connective tissue disorders
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0031 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Lacrimation Increased
Eye disorders
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0031 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 17.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected13 at risk
EG0020 affected12 at risk
EG0031 affected12 at risk
EG0040 affected65 at risk
EG0050 affected65 at risk
EG0060 affected64 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.