Trial Outcomes & Findings for A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis (NCT NCT03880266)
NCT ID: NCT03880266
Last Updated: 2021-08-25
Results Overview
The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis \[score on a scale from 0 (better) -10 (worse)\].
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Baseline, Week 2
Results posted on
2021-08-25
Participant Flow
Participant milestones
| Measure |
Group 1 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 1 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 2 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 2 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 3 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
|
Group 3 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
|
Group 4 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
|
Group 4 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
12
|
4
|
12
|
6
|
13
|
7
|
|
Overall Study
COMPLETED
|
12
|
5
|
11
|
4
|
12
|
6
|
13
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 1 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 2 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 2 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 3 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
|
Group 3 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
|
Group 4 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
|
Group 4 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
Baseline characteristics by cohort
| Measure |
Group 1 Active
n=12 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 1 Vehicle
n=6 Participants
Vehicle applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 2 Active
n=12 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 2 Vehicle
n=4 Participants
Vehicle applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 3 Active
n=12 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
|
Group 3 Vehicle
n=6 Participants
Vehicle applied to the hands once daily for 14 days: 15 minutes
|
Group 4 Active
n=13 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
|
Group 4 Vehicle
n=7 Participants
Vehicle applied to the hands once daily for 14 days: 30 minutes
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 15.93 • n=7 Participants
|
29.2 years
STANDARD_DEVIATION 11.57 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 17.56 • n=4 Participants
|
28.2 years
STANDARD_DEVIATION 12.45 • n=21 Participants
|
32.5 years
STANDARD_DEVIATION 7.97 • n=10 Participants
|
26.6 years
STANDARD_DEVIATION 9.54 • n=115 Participants
|
37.1 years
STANDARD_DEVIATION 13.91 • n=6 Participants
|
31.1 years
STANDARD_DEVIATION 12.27 • n=6 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
47 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
25 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
53 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
4 participants
n=4 Participants
|
12 participants
n=21 Participants
|
6 participants
n=10 Participants
|
13 participants
n=115 Participants
|
7 participants
n=6 Participants
|
72 participants
n=6 Participants
|
|
Hand Sweat Severity Score
|
6.78 units on a scale
STANDARD_DEVIATION 1.646 • n=5 Participants
|
7.40 units on a scale
STANDARD_DEVIATION 0.718 • n=7 Participants
|
7.56 units on a scale
STANDARD_DEVIATION 1.450 • n=5 Participants
|
8.10 units on a scale
STANDARD_DEVIATION 1.920 • n=4 Participants
|
6.93 units on a scale
STANDARD_DEVIATION 1.689 • n=21 Participants
|
7.37 units on a scale
STANDARD_DEVIATION 2.017 • n=10 Participants
|
7.58 units on a scale
STANDARD_DEVIATION 1.399 • n=115 Participants
|
8.01 units on a scale
STANDARD_DEVIATION 1.078 • n=6 Participants
|
7.37 units on a scale
STANDARD_DEVIATION 1.51 • n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2Population: Intent to Treat Population
The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis \[score on a scale from 0 (better) -10 (worse)\].
Outcome measures
| Measure |
Group 1 Active
n=12 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 1 Vehicle
n=5 Participants
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 2 Active
n=11 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 2 Vehicle
n=4 Participants
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 3 Active
n=12 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
|
Group 3 Vehicle
n=6 Participants
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
|
Group 4 Active
n=13 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
|
Group 4 Vehicle
n=7 Participants
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
|
-2.14 score on a scale
Standard Deviation 2.199
|
-0.56 score on a scale
Standard Deviation 0.730
|
-1.64 score on a scale
Standard Deviation 1.410
|
-3.03 score on a scale
Standard Deviation 2.161
|
-2.53 score on a scale
Standard Deviation 2.223
|
-2.20 score on a scale
Standard Deviation 1.084
|
-1.30 score on a scale
Standard Deviation 2.062
|
-1.34 score on a scale
Standard Deviation 1.909
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Intent to Treat Population
Hyperhidrosis Disease Severity Scale (HDSS) is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities. 1 (better), 2, 3, 4 (worse)
Outcome measures
| Measure |
Group 1 Active
n=12 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 1 Vehicle
n=5 Participants
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 2 Active
n=10 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 2 Vehicle
n=4 Participants
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 3 Active
n=11 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
|
Group 3 Vehicle
n=6 Participants
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
|
Group 4 Active
n=13 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
|
Group 4 Vehicle
n=7 Participants
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Intent to Treat Population
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; average of the change in the gravimetric measurement of sweat produced at baseline compared with Week 2
Outcome measures
| Measure |
Group 1 Active
n=12 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 1 Vehicle
n=5 Participants
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 2 Active
n=11 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 2 Vehicle
n=4 Participants
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 3 Active
n=12 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
|
Group 3 Vehicle
n=6 Participants
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
|
Group 4 Active
n=13 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
|
Group 4 Vehicle
n=7 Participants
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
|
-69.8 mg
Standard Deviation 162.54
|
136.7 mg
Standard Deviation 320.57
|
-15.3 mg
Standard Deviation 53.14
|
-159.4 mg
Standard Deviation 354.38
|
-113.5 mg
Standard Deviation 164.10
|
38.1 mg
Standard Deviation 106.30
|
-58.6 mg
Standard Deviation 139.70
|
102.0 mg
Standard Deviation 767.52
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Intent to Treat Population
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; calculation of percentage difference in sweat production at week 2 compared to baseline sweat production
Outcome measures
| Measure |
Group 1 Active
n=12 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 1 Vehicle
n=5 Participants
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 2 Active
n=11 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 2 Vehicle
n=4 Participants
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 3 Active
n=12 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
|
Group 3 Vehicle
n=6 Participants
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
|
Group 4 Active
n=13 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
|
Group 4 Vehicle
n=7 Participants
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
|
-17.1 Percent change
Standard Deviation 28.26
|
16.5 Percent change
Standard Deviation 60.4
|
-7.5 Percent change
Standard Deviation 65.53
|
-31.8 Percent change
Standard Deviation 51.29
|
-26.8 Percent change
Standard Deviation 39.17
|
11.4 Percent change
Standard Deviation 34.96
|
-17.7 Percent change
Standard Deviation 40.43
|
21.7 Percent change
Standard Deviation 145.81
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Intent to Treat Population
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; confidence interval represents difference between vehicle and active group
Outcome measures
| Measure |
Group 1 Active
n=12 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 1 Vehicle
n=5 Participants
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 2 Active
n=11 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 2 Vehicle
n=4 Participants
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 3 Active
n=12 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
|
Group 3 Vehicle
n=6 Participants
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
|
Group 4 Active
n=13 Participants
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
|
Group 4 Vehicle
n=7 Participants
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
Adverse Events
Group 1 Active
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 1 Vehicle
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2 Active
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2 Vehicle
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 3 Active
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 3 Vehicle
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 4 Active
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 4 Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 Active
n=12 participants at risk
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 1 Vehicle
n=6 participants at risk
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Group 2 Active
n=12 participants at risk
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 2 Vehicle
n=4 participants at risk
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Group 3 Active
n=12 participants at risk
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
|
Group 3 Vehicle
n=6 participants at risk
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
|
Group 4 Active
n=13 participants at risk
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
|
Group 4 Vehicle
n=7 participants at risk
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
16.7%
1/6 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
25.0%
1/4 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Gastrointestinal disorders
Dry Mouth
|
8.3%
1/12 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
16.7%
1/6 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
16.7%
2/12 • Number of events 2 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
8.3%
1/12 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
16.7%
1/6 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
8.3%
1/12 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Injury, poisoning and procedural complications
Compensatory sweating
|
8.3%
1/12 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
8.3%
1/12 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
16.7%
1/6 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Eye disorders
Dry eye
|
8.3%
1/12 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Eye disorders
Photophobia
|
8.3%
1/12 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
8.3%
1/12 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
16.7%
1/6 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
General disorders
Application site pruritus
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
7.7%
1/13 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Investigations
White blood cell count increased
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
8.3%
1/12 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/13 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/4 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/12 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/6 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
7.7%
1/13 • Number of events 1 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
0.00%
0/7 • Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place