Trial Outcomes & Findings for A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis (NCT NCT02016885)
NCT ID: NCT02016885
Last Updated: 2021-08-25
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
198 participants
Primary outcome timeframe
Baseline - Week 4
Results posted on
2021-08-25
Participant Flow
Participant milestones
| Measure |
Glycopyrrolate, 1.0%
glycopyrrolate Topical Wipes, 1.0%
|
Glycopyrrolate, 2.0%
glycopyrrolate Topical Wipes, 2.0%
|
Glycopyrrolate, 3.0%
glycopyrrolate Topical Wipes, 3.0%
|
Glycopyrrolate, 4.0%
glycopyrrolate Topical Wipes, 4.0%
|
Vehicle
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
38
|
40
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
34
|
36
|
39
|
30
|
39
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
1
|
10
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Baseline characteristics by cohort
| Measure |
Glycopyrrolate, 1.0%
n=38 Participants
glycopyrrolate Topical Wipes, 1.0%
|
Glycopyrrolate, 2.0%
n=40 Participants
glycopyrrolate Topical Wipes, 2.0%
|
Glycopyrrolate, 3.0%
n=40 Participants
glycopyrrolate Topical Wipes, 3.0%
|
Glycopyrrolate, 4.0%
n=40 Participants
glycopyrrolate Topical Wipes, 4.0%
|
Vehicle
n=40 Participants
Vehicle Topical Wipes
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
189 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
98 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
100 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
177 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
169 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: Baseline - Week 4Population: 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 |
Glycopyrrolate, 1.0%
n=38 Participants
glycopyrrolate Topical Wipes, 1.0%
|
Glycopyrrolate, 2.0%
n=40 Participants
glycopyrrolate Topical Wipes, 2.0%
|
Glycopyrrolate, 3.0%
n=40 Participants
glycopyrrolate Topical Wipes, 3.0%
|
Glycopyrrolate, 4.0%
n=40 Participants
glycopyrrolate Topical Wipes, 4.0%
|
Vehicle
n=40 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
|
14 Participants
|
20 Participants
|
21 Participants
|
18 Participants
|
9 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 |
Glycopyrrolate, 1.0%
n=38 Participants
glycopyrrolate Topical Wipes, 1.0%
|
Glycopyrrolate, 2.0%
n=40 Participants
glycopyrrolate Topical Wipes, 2.0%
|
Glycopyrrolate, 3.0%
n=40 Participants
glycopyrrolate Topical Wipes, 3.0%
|
Glycopyrrolate, 4.0%
n=40 Participants
glycopyrrolate Topical Wipes, 4.0%
|
Vehicle
n=40 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4
|
-56.63 mg/5 min
Standard Deviation 75.02
|
-67.17 mg/5 min
Standard Deviation 61.26
|
-91.39 mg/5 min
Standard Deviation 71.27
|
-88.40 mg/5 min
Standard Deviation 103.85
|
-55.80 mg/5 min
Standard Deviation 80.65
|
SECONDARY outcome
Timeframe: Baseline - Week 4Population: Participant
Outcome measures
| Measure |
Glycopyrrolate, 1.0%
n=38 Participants
glycopyrrolate Topical Wipes, 1.0%
|
Glycopyrrolate, 2.0%
n=40 Participants
glycopyrrolate Topical Wipes, 2.0%
|
Glycopyrrolate, 3.0%
n=40 Participants
glycopyrrolate Topical Wipes, 3.0%
|
Glycopyrrolate, 4.0%
n=40 Participants
glycopyrrolate Topical Wipes, 4.0%
|
Vehicle
n=40 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
|
27 Participants
|
30 Participants
|
35 Participants
|
25 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Baseline - Week 6Population: Participant
Outcome measures
| Measure |
Glycopyrrolate, 1.0%
n=38 Participants
glycopyrrolate Topical Wipes, 1.0%
|
Glycopyrrolate, 2.0%
n=40 Participants
glycopyrrolate Topical Wipes, 2.0%
|
Glycopyrrolate, 3.0%
n=40 Participants
glycopyrrolate Topical Wipes, 3.0%
|
Glycopyrrolate, 4.0%
n=40 Participants
glycopyrrolate Topical Wipes, 4.0%
|
Vehicle
n=40 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
|
-32.08 mg/5 min
Standard Deviation 68.55
|
-51.36 mg/5 min
Standard Deviation 52.30
|
-72.23 mg/5 min
Standard Deviation 64.21
|
-57.15 mg/5 min
Standard Deviation 165.66
|
-55.14 mg/5 min
Standard Deviation 56.92
|
SECONDARY outcome
Timeframe: Baseline - Week 6Population: Participant
Outcome measures
| Measure |
Glycopyrrolate, 1.0%
n=38 Participants
glycopyrrolate Topical Wipes, 1.0%
|
Glycopyrrolate, 2.0%
n=40 Participants
glycopyrrolate Topical Wipes, 2.0%
|
Glycopyrrolate, 3.0%
n=40 Participants
glycopyrrolate Topical Wipes, 3.0%
|
Glycopyrrolate, 4.0%
n=40 Participants
glycopyrrolate Topical Wipes, 4.0%
|
Vehicle
n=40 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
|
24 Participants
|
27 Participants
|
29 Participants
|
23 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline - Week 4Population: Participant
The DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.
Outcome measures
| Measure |
Glycopyrrolate, 1.0%
n=38 Participants
glycopyrrolate Topical Wipes, 1.0%
|
Glycopyrrolate, 2.0%
n=40 Participants
glycopyrrolate Topical Wipes, 2.0%
|
Glycopyrrolate, 3.0%
n=40 Participants
glycopyrrolate Topical Wipes, 3.0%
|
Glycopyrrolate, 4.0%
n=40 Participants
glycopyrrolate Topical Wipes, 4.0%
|
Vehicle
n=40 Participants
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4
|
-6.2 scores on a scale
Standard Deviation 6.0
|
-6.6 scores on a scale
Standard Deviation 4.9
|
-7.0 scores on a scale
Standard Deviation 5.1
|
-5.9 scores on a scale
Standard Deviation 4.7
|
-3.8 scores on a scale
Standard Deviation 4.6
|
Adverse Events
Glycopyrrolate, 1.0%
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Glycopyrrolate, 2.0%
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Glycopyrrolate, 3.0%
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Glycopyrrolate, 4.0%
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Glycopyrrolate, 1.0%
n=36 participants at risk
glycopyrrolate Topical Wipes, 1.0%
|
Glycopyrrolate, 2.0%
n=39 participants at risk
glycopyrrolate Topical Wipes, 2.0%
|
Glycopyrrolate, 3.0%
n=40 participants at risk
glycopyrrolate Topical Wipes, 3.0%
|
Glycopyrrolate, 4.0%
n=40 participants at risk
glycopyrrolate Topical Wipes, 4.0%
|
Vehicle
n=39 participants at risk
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/36 • 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%
0/39 • 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.
|
2.5%
1/40 • Number of events 1 • 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%
0/40 • 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%
0/39 • 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.
|
Other adverse events
| Measure |
Glycopyrrolate, 1.0%
n=36 participants at risk
glycopyrrolate Topical Wipes, 1.0%
|
Glycopyrrolate, 2.0%
n=39 participants at risk
glycopyrrolate Topical Wipes, 2.0%
|
Glycopyrrolate, 3.0%
n=40 participants at risk
glycopyrrolate Topical Wipes, 3.0%
|
Glycopyrrolate, 4.0%
n=40 participants at risk
glycopyrrolate Topical Wipes, 4.0%
|
Vehicle
n=39 participants at risk
Vehicle Topical Wipes
|
|---|---|---|---|---|---|
|
Eye disorders
Mydriasis
|
5.6%
2/36 • 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.
|
2.6%
1/39 • 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%
0/40 • 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.
|
2.5%
1/40 • 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%
0/39 • 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%
0/36 • 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.
|
5.1%
2/39 • 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.
|
2.5%
1/40 • 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.
|
10.0%
4/40 • 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%
0/39 • 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%
0/36 • 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.
|
10.3%
4/39 • 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%
2/40 • 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%
2/40 • 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.
|
5.1%
2/39 • 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
|
2.8%
1/36 • 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.
|
2.6%
1/39 • 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.
|
2.5%
1/40 • 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%
2/40 • 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%
0/39 • 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
|
13.9%
5/36 • 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.
|
23.1%
9/39 • 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.
|
35.0%
14/40 • 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.
|
37.5%
15/40 • 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.
|
12.8%
5/39 • 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
Sinusitis
|
0.00%
0/36 • 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%
0/39 • 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%
0/40 • 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.
|
2.5%
1/40 • 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.
|
5.1%
2/39 • 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
|
5.6%
2/36 • 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.
|
2.6%
1/39 • 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.
|
7.5%
3/40 • 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.
|
2.5%
1/40 • 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.
|
7.7%
3/39 • 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
Dysuria
|
0.00%
0/36 • 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%
0/39 • 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.
|
2.5%
1/40 • 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.
|
7.5%
3/40 • 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%
0/39 • 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%
0/36 • 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.
|
2.6%
1/39 • 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%
0/40 • 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.
|
7.5%
3/40 • 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%
0/39 • 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
Epistaxis
|
0.00%
0/36 • 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%
0/39 • 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.
|
2.5%
1/40 • 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%
2/40 • 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%
0/39 • 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%
0/36 • 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.
|
5.1%
2/39 • 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.
|
2.5%
1/40 • 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%
2/40 • 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%
0/39 • 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
Oropharyngeal pain
|
0.00%
0/36 • 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.
|
2.6%
1/39 • 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%
0/40 • 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%
2/40 • 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%
0/39 • 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
Dry skin
|
0.00%
0/36 • 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.
|
5.1%
2/39 • 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.
|
7.5%
3/40 • 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%
2/40 • 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%
0/39 • 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
Hyperhidrosis
|
0.00%
0/36 • 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.
|
5.1%
2/39 • 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%
0/40 • 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%
0/40 • 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%
0/39 • 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%
0/36 • 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%
0/39 • 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.
|
2.5%
1/40 • 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%
2/40 • 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%
0/39 • 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
Application Site Folliculitis
|
0.00%
0/36 • 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.
|
5.1%
2/39 • 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.
|
2.5%
1/40 • 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.
|
2.5%
1/40 • 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%
0/39 • 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