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Trial record 5 of 10 for:    bimatoprost alopecia

A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01904721
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : December 9, 2015
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Alopecia
Alopecia, Androgenetic
Baldness
Interventions Drug: Bimatoprost Solution 1
Drug: Bimatoprost Solution 2
Drug: Bimatoprost Vehicle
Enrollment 244
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stage 1: Bimatoprost Solution 1 Twice Daily Stage 1: Bimatoprost Solution 1 Once Daily Stage 1: Bimatoprost Solution 2 Twice Daily Stage 1: Bimatoprost Solution 2 Once Daily Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Vehicle Twice Daily
Hide Arm/Group Description Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days. Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days. Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days. Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days. Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months. Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months. Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Period Title: Overall Study
Started 13 13 12 12 65 65 64
Completed 13 13 11 11 57 56 57
Not Completed 0 0 1 1 8 9 7
Reason Not Completed
Other Reasons             0             0             1             1             2             2             2
Personal Reasons             0             0             0             0             2             3             3
Lost to Follow-up             0             0             0             0             1             3             1
Lack of Efficacy             0             0             0             0             0             0             1
Adverse Event             0             0             0             0             3             1             0
Arm/Group Title Stage 1: Bimatoprost Solution 1 Twice Daily Stage 1: Bimatoprost Solution 1 Once Daily Stage 1: Bimatoprost Solution 2 Twice Daily Stage 1: Bimatoprost Solution 2 Once Daily Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Vehicle Twice Daily Total
Hide Arm/Group Description Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days. Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days. Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days. Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days. Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months. Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months. Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months. Total of all reporting groups
Overall Number of Baseline Participants 13 13 12 12 65 65 64 244
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 12 participants 12 participants 65 participants 65 participants 64 participants 244 participants
≥18 to <35 years 8 0 3 3 17 18 17 66
35 to 49 years 5 13 9 9 48 47 47 178
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Male Number Analyzed 13 participants 13 participants 12 participants 12 participants 65 participants 65 participants 64 participants 244 participants
13 13 12 12 65 65 64 244
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) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Arm/Group Title Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Vehicle Twice Daily
Hide Arm/Group Description:
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Overall Number of Participants Analyzed 63 62 60
Mean (Standard Deviation)
Unit of Measure: terminal hairs/cm2
Baseline 131.3  (55.53) 140.4  (59.76) 129.0  (57.42)
Change from Baseline at Month 6 9.3  (23.09) 12.7  (26.39) 5.8  (20.95)
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 Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Arm/Group Title Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Vehicle Twice Daily
Hide Arm/Group Description:
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Overall Number of Participants Analyzed 63 62 60
Measure Type: Number
Unit of Measure: Percentage of Participants
Greatly increased 4.8 6.5 0.0
Moderately increased 25.4 14.5 6.7
Slightly increased 33.3 33.9 20.0
Remained the same 23.8 30.6 35.0
Slightly decreased 12.7 12.9 30.0
Moderately decreased 0.0 1.6 6.7
Greatly decreased 0.0 0.0 1.7
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 Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Arm/Group Title Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Vehicle Twice Daily
Hide Arm/Group Description:
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Overall Number of Participants Analyzed 63 62 60
Measure Type: Number
Unit of Measure: Percentage of Participants
Greatly increased 4.8 11.3 0.0
Moderately increased 22.2 17.7 3.3
Slightly increased 33.3 25.8 23.3
Remained the same 36.5 41.9 60.0
Slightly decreased 3.2 3.2 13.3
Moderately decreased 0.0 0.0 0.0
Greatly decreased 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 Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Arm/Group Title Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Vehicle Twice Daily
Hide Arm/Group Description:
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Overall Number of Participants Analyzed 62 60 58
Measure Type: Number
Unit of Measure: Percentage of Participants
Greatly increased 1.6 3.3 0.0
Moderately increased 9.7 15.0 0.0
Slightly increased 40.3 35.0 15.5
Remained the same 45.2 43.3 72.4
Slightly decreased 3.2 3.3 10.3
Moderately decreased 0.0 0.0 1.7
Greatly decreased 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) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Arm/Group Title Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Vehicle Twice Daily
Hide Arm/Group Description:
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Overall Number of Participants Analyzed 63 62 60
Mean (Standard Deviation)
Unit of Measure: mm/cm2
Baseline 7.32  (3.472) 7.82  (3.764) 7.30  (3.550)
Change from Baseline at Month 6 0.67  (1.185) 0.92  (1.435) 0.05  (1.018)
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) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs).
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Arm/Group Title Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Vehicle Twice Daily
Hide Arm/Group Description:
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Overall Number of Participants Analyzed 63 62 60
Mean (Standard Deviation)
Unit of Measure: Intensity Units
Baseline 113.77  (19.458) 115.76  (20.014) 115.22  (19.879)
Change from Baseline at Month 6 -1.63  (17.896) -6.31  (17.016) -1.62  (16.763)
Time Frame [Not Specified]
Adverse Event Reporting 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.
 
Arm/Group Title Stage 1: Bimatoprost Solution 1 Twice Daily Stage 1: Bimatoprost Solution 1 Once Daily Stage 1: Bimatoprost Solution 2 Twice Daily Stage 1: Bimatoprost Solution 2 Once Daily Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Vehicle Twice Daily
Hide Arm/Group Description Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days. Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days. Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days. Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days. Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months. Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months. Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
All-Cause Mortality
Stage 1: Bimatoprost Solution 1 Twice Daily Stage 1: Bimatoprost Solution 1 Once Daily Stage 1: Bimatoprost Solution 2 Twice Daily Stage 1: Bimatoprost Solution 2 Once Daily Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Vehicle Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stage 1: Bimatoprost Solution 1 Twice Daily Stage 1: Bimatoprost Solution 1 Once Daily Stage 1: Bimatoprost Solution 2 Twice Daily Stage 1: Bimatoprost Solution 2 Once Daily Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Vehicle Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   1/65 (1.54%)   2/65 (3.08%)   0/64 (0.00%) 
Cardiac disorders               
Coronary Artery Occlusion  1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/65 (0.00%)  1/65 (1.54%)  0/64 (0.00%) 
Myocardial Infarction  1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/65 (0.00%)  1/65 (1.54%)  0/64 (0.00%) 
Injury, poisoning and procedural complications               
Clavicle Fracture  1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/65 (1.54%)  0/65 (0.00%)  0/64 (0.00%) 
Road Traffic Accident * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/65 (1.54%)  0/65 (0.00%)  0/64 (0.00%) 
Scapula Fracture  1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/65 (1.54%)  0/65 (0.00%)  0/64 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Pneumothorax  1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/65 (1.54%)  0/65 (0.00%)  0/64 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stage 1: Bimatoprost Solution 1 Twice Daily Stage 1: Bimatoprost Solution 1 Once Daily Stage 1: Bimatoprost Solution 2 Twice Daily Stage 1: Bimatoprost Solution 2 Once Daily Stage 2: Bimatoprost Solution 2 Twice Daily Stage 2: Bimatoprost Solution 1 Twice Daily Stage 2: Bimatoprost Vehicle Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/13 (38.46%)   4/13 (30.77%)   7/12 (58.33%)   1/12 (8.33%)   25/65 (38.46%)   25/65 (38.46%)   7/64 (10.94%) 
Cardiac disorders               
Atrioventricular Block First Degree  1  0/13 (0.00%)  2/13 (15.38%)  0/12 (0.00%)  0/12 (0.00%)  1/65 (1.54%)  1/65 (1.54%)  1/64 (1.56%) 
Atrial Fibrillation  1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Bundle Branch Block Left  1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%)  0/65 (0.00%)  1/65 (1.54%)  0/64 (0.00%) 
Eye disorders               
Growth of Eyelashes * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  10/65 (15.38%)  0/65 (0.00%)  0/64 (0.00%) 
Conjunctival Hyperaemia  1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Dry Eye * 1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%)  2/65 (3.08%)  0/65 (0.00%)  0/64 (0.00%) 
Corneal Irritation  1  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Eye Pruritus * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  1/65 (1.54%)  0/65 (0.00%)  0/64 (0.00%) 
Lacrimation Increased * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Gastrointestinal disorders               
Dyspepsia * 1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
General disorders               
Influenza Like Illness * 1  2/13 (15.38%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Application Site Pruritus * 1  1/13 (7.69%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  1/65 (1.54%)  2/65 (3.08%)  0/64 (0.00%) 
Application Site Erythema * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  3/65 (4.62%)  5/65 (7.69%)  2/64 (3.13%) 
Application Site Discoloration * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/65 (1.54%)  4/65 (6.15%)  1/64 (1.56%) 
Infections and infestations               
Upper Respiratory Tract Infection * 1  0/13 (0.00%)  0/13 (0.00%)  2/12 (16.67%)  1/12 (8.33%)  1/65 (1.54%)  2/65 (3.08%)  1/64 (1.56%) 
Folliculitis * 1  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Ear Lobe Infection * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Investigations               
Electrocardiogram T Wave Amplitude Increased  1  1/13 (7.69%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Blood Glucose Increased  1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/65 (0.00%)  0/65 (0.00%)  1/64 (1.56%) 
Glucose Urine Present  1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Musculoskeletal and connective tissue disorders               
Back Pain * 1  1/13 (7.69%)  0/13 (0.00%)  2/12 (16.67%)  0/12 (0.00%)  0/65 (0.00%)  0/65 (0.00%)  1/64 (1.56%) 
Joint Swelling * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Nervous system disorders               
Headache * 1  0/13 (0.00%)  2/13 (15.38%)  0/12 (0.00%)  0/12 (0.00%)  0/65 (0.00%)  3/65 (4.62%)  1/64 (1.56%) 
Respiratory, thoracic and mediastinal disorders               
Sinus Congestion * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Skin and subcutaneous tissue disorders               
Hair Growth Abnormal * 1  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  6/65 (9.23%)  2/65 (3.08%)  0/64 (0.00%) 
Hypertrichosis * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  5/65 (7.69%)  6/65 (9.23%)  0/64 (0.00%) 
Dermatitis Contact * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/65 (1.54%)  0/65 (0.00%)  0/64 (0.00%) 
Skin Irritation * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/65 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.1
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: NCT01904721     History of Changes
Other Study ID Numbers: 192024-084
First Submitted: July 18, 2013
First Posted: July 22, 2013
Results First Submitted: November 4, 2015
Results First Posted: December 9, 2015
Last Update Posted: March 22, 2016