Trial Outcomes & Findings for Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis (NCT NCT02129660)
NCT ID: NCT02129660
Last Updated: 2025-09-17
Results Overview
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 (Best), 2, 3, 4 (Worst)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
Baseline - Week 4/ET
Results posted on
2025-09-17
Participant Flow
Participant milestones
| Measure |
Dose 1 of Glycopyrrolate
Dose 1 of glycopyrrolate Topical Wipes
|
Dose 2 of Glycopyrrolate
Dose 2 of glycopyrrolate Topical Wipes
|
Dose 1 of Glycopyrronium
Dose 1 of glycopyrronium Topical Wipes
|
Dose 2 of Glycopyrronium
Dose 2 of glycopyrronium Topical Wipes
|
Vehicle
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
22
|
20
|
22
|
|
Overall Study
COMPLETED
|
19
|
20
|
21
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis
Baseline characteristics by cohort
| Measure |
Dose 1 of Glycopyrrolate
n=21 Participants
Dose 1 of glycopyrrolate Topical Wipes
|
Dose 2 of Glycopyrrolate
n=20 Participants
Dose 2 of glycopyrrolate Topical Wipes
|
Dose 1 of Glycopyrronium
n=22 Participants
Dose 1 of glycopyrronium Topical Wipes
|
Dose 2 of Glycopyrronium
n=20 Participants
Dose 2 of glycopyrronium Topical Wipes
|
Vehicle
n=22 Participants
Vehicle Topical Wipes
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
99 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
48 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
57 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
100 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
91 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline - Week 4/ETPopulation: Participant
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 (Best), 2, 3, 4 (Worst)
Outcome measures
| Measure |
Dose 1 of Glycopyrrolate
n=21 Participants
Dose 1 of glycopyrrolate Topical Wipes
|
Dose 2 of Glycopyrrolate
n=20 Participants
Dose 2 of glycopyrrolate Topical Wipes
|
Dose 1 of Glycopyrronium
n=22 Participants
Dose 1 of glycopyrronium Topical Wipes
|
Dose 2 of Glycopyrronium
n=20 Participants
Dose 2 of glycopyrronium Topical Wipes
|
Vehicle
n=22 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
|
10 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Baseline - Week 4Population: Participant
Outcome measures
| Measure |
Dose 1 of Glycopyrrolate
n=21 Participants
Dose 1 of glycopyrrolate Topical Wipes
|
Dose 2 of Glycopyrrolate
n=20 Participants
Dose 2 of glycopyrrolate Topical Wipes
|
Dose 1 of Glycopyrronium
n=22 Participants
Dose 1 of glycopyrronium Topical Wipes
|
Dose 2 of Glycopyrronium
n=20 Participants
Dose 2 of glycopyrronium Topical Wipes
|
Vehicle
n=22 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
|
16 Participants
|
17 Participants
|
15 Participants
|
14 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Baseline - Week 6Population: Participant
Outcome measures
| Measure |
Dose 1 of Glycopyrrolate
n=21 Participants
Dose 1 of glycopyrrolate Topical Wipes
|
Dose 2 of Glycopyrrolate
n=20 Participants
Dose 2 of glycopyrrolate Topical Wipes
|
Dose 1 of Glycopyrronium
n=22 Participants
Dose 1 of glycopyrronium Topical Wipes
|
Dose 2 of Glycopyrronium
n=20 Participants
Dose 2 of glycopyrronium Topical Wipes
|
Vehicle
n=22 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
|
19 Participants
|
16 Participants
|
17 Participants
|
13 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Baseline - Week 4Population: Participant
Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.
Outcome measures
| Measure |
Dose 1 of Glycopyrrolate
n=21 Participants
Dose 1 of glycopyrrolate Topical Wipes
|
Dose 2 of Glycopyrrolate
n=20 Participants
Dose 2 of glycopyrrolate Topical Wipes
|
Dose 1 of Glycopyrronium
n=22 Participants
Dose 1 of glycopyrronium Topical Wipes
|
Dose 2 of Glycopyrronium
n=20 Participants
Dose 2 of glycopyrronium Topical Wipes
|
Vehicle
n=22 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4
|
-104.20 mg/5 min
Standard Deviation 73.73
|
-58.27 mg/5 min
Standard Deviation 31.00
|
-105.28 mg/5 min
Standard Deviation 95.83
|
-72.69 mg/5 min
Standard Deviation 82.48
|
-53.85 mg/5 min
Standard Deviation 70.65
|
PRIMARY outcome
Timeframe: Baseline - Week 6Population: Participant
Outcome measures
| Measure |
Dose 1 of Glycopyrrolate
n=21 Participants
Dose 1 of glycopyrrolate Topical Wipes
|
Dose 2 of Glycopyrrolate
n=20 Participants
Dose 2 of glycopyrrolate Topical Wipes
|
Dose 1 of Glycopyrronium
n=22 Participants
Dose 1 of glycopyrronium Topical Wipes
|
Dose 2 of Glycopyrronium
n=20 Participants
Dose 2 of glycopyrronium Topical Wipes
|
Vehicle
n=22 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
|
-92.20 mg/5 min
Standard Deviation 74.87
|
-44.37 mg/5 min
Standard Deviation 40.92
|
-96.98 mg/5 min
Standard Deviation 103.38
|
-66.17 mg/5 min
Standard Deviation 78.96
|
-71.06 mg/5 min
Standard Deviation 64.82
|
SECONDARY outcome
Timeframe: Baseline - Week 4Population: Participant
Outcome measures
| Measure |
Dose 1 of Glycopyrrolate
n=21 Participants
Dose 1 of glycopyrrolate Topical Wipes
|
Dose 2 of Glycopyrrolate
n=20 Participants
Dose 2 of glycopyrrolate Topical Wipes
|
Dose 1 of Glycopyrronium
n=22 Participants
Dose 1 of glycopyrronium Topical Wipes
|
Dose 2 of Glycopyrronium
n=20 Participants
Dose 2 of glycopyrronium Topical Wipes
|
Vehicle
n=22 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
|
19 Participants
|
16 Participants
|
20 Participants
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline - Week 6Population: Participant
Outcome measures
| Measure |
Dose 1 of Glycopyrrolate
n=21 Participants
Dose 1 of glycopyrrolate Topical Wipes
|
Dose 2 of Glycopyrrolate
n=20 Participants
Dose 2 of glycopyrrolate Topical Wipes
|
Dose 1 of Glycopyrronium
n=22 Participants
Dose 1 of glycopyrronium Topical Wipes
|
Dose 2 of Glycopyrronium
n=20 Participants
Dose 2 of glycopyrronium Topical Wipes
|
Vehicle
n=22 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6
|
15 Participants
|
15 Participants
|
17 Participants
|
16 Participants
|
14 Participants
|
Adverse Events
Dose 1 of Glycopyrrolate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose 2 of Glycopyrrolate
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Dose 1 of Glycopyrronium
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Dose 2 of Glycopyrronium
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose 1 of Glycopyrrolate
n=21 participants at risk
Dose 1 of glycopyrrolate Topical Wipes
|
Dose 2 of Glycopyrrolate
n=20 participants at risk
Dose 2 of glycopyrrolate Topical Wipes
|
Dose 1 of Glycopyrronium
n=22 participants at risk
Dose 1 of glycopyrronium Topical Wipes
|
Dose 2 of Glycopyrronium
n=20 participants at risk
Dose 2 of glycopyrronium Topical Wipes
|
Vehicle
n=21 participants at risk
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Eye disorders
Mydriasis
|
4.8%
1/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
4.5%
1/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
14.3%
3/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
20.0%
4/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
27.3%
6/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
25.0%
5/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
4.8%
1/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
General disorders
Application Site Pain
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
23.8%
5/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
4.5%
1/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental Exposure to Product
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
9.1%
2/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Gastrointestinal disorders
Decrease Appetite
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
General disorders
Drug Interaction
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
13.6%
3/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
General disorders
Injection Site Bruising
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
4.5%
1/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
4.8%
1/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
9.1%
2/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
9.1%
2/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/22 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
5.0%
1/20 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/21 • 6 weeks
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
|
Additional Information
Eugene A. Bauer, MD, Chief Medical Officer
Dermira, Inc.
Phone: 650-421-7202
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place