Trial Outcomes & Findings for Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis (NCT NCT02530294)

Last Updated: 2021-08-25

Results Overview

The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are: 1. During the past 24 hours, did you have any underarm sweating? (Yes or No) 2. During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating) 3. During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount) 4. During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

353 participants

Primary outcome timeframe

From Baseline to Week 4

Results posted on

2021-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Glycopyrronium glycopyrronium Topical Wipes	Vehicle glycopyrronium Topical Wipes, Vehicle
Overall Study STARTED	234	119
Overall Study COMPLETED	218	113
Overall Study NOT COMPLETED	16	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glycopyrronium n=234 Participants glycopyrronium Topical Wipes	Vehicle n=119 Participants glycopyrronium Topical Wipes, Vehicle	Total n=353 Participants Total of all reporting groups
Age, Categorical <=18 years	24 Participants n=5 Participants	15 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	210 Participants n=5 Participants	104 Participants n=7 Participants	314 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	121 Participants n=5 Participants	60 Participants n=7 Participants	181 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants	59 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	15 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	206 Participants n=5 Participants	104 Participants n=7 Participants	310 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants	14 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) White	192 Participants n=5 Participants	102 Participants n=7 Participants	294 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 4

Population: Participant

Outcome measures

Outcome measures
Measure	Glycopyrronium n=234 Participants glycopyrronium Topical Wipes	Vehicle n=119 Participants glycopyrronium Topical Wipes, Vehicle
Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of Axillary Sweating Daily Diary (ASDD) Item #2 From Baseline at Week 4	66.1 percent of subjects	26.9 percent of subjects

PRIMARY outcome

Timeframe: Baseline - Week 4

Population: 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

Outcome measures
Measure	Glycopyrronium n=234 Participants glycopyrronium Topical Wipes	Vehicle n=119 Participants glycopyrronium Topical Wipes, Vehicle
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4	-115.43 mg/5 min Standard Deviation 66.511	-81.20 mg/5 min Standard Deviation 66.714

PRIMARY outcome

Timeframe: From Baseline to Week 4

Population: Participant

Outcome measures

Outcome measures
Measure	Glycopyrronium n=234 Participants glycopyrronium Topical Wipes	Vehicle n=119 Participants glycopyrronium Topical Wipes, Vehicle
Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4	-78.77 mg/5 min Interval -143.97 to -45.48	-57.94 mg/5 min Interval -121.85 to -21.16

SECONDARY outcome

Timeframe: From Baseline to Week 4

Population: Participant

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.

Outcome measures

Outcome measures
Measure	Glycopyrronium n=234 Participants glycopyrronium Topical Wipes	Vehicle n=119 Participants glycopyrronium Topical Wipes, Vehicle
Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4	61.6 percent of subjects	27.8 percent of subjects

SECONDARY outcome

Timeframe: From Baseline to Week 4

Population: Participant

Outcome measures

Outcome measures
Measure	Glycopyrronium n=234 Participants glycopyrronium Topical Wipes	Vehicle n=119 Participants glycopyrronium Topical Wipes, Vehicle
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4	77.3 percent of subjects	53.3 percent of subjects

Adverse Events

Glycopyrronium

Serious events: 1 serious events

Other events: 101 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Glycopyrronium n=232 participants at risk glycopyrronium Topical Wipes	Vehicle n=118 participants at risk glycopyrronium Topical Wipes, Vehicle
Metabolism and nutrition disorders Dehydration	0.43% 1/232 • Up to 35 days 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% 0/118 • Up to 35 days 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

Other adverse events
Measure	Glycopyrronium n=232 participants at risk glycopyrronium Topical Wipes	Vehicle n=118 participants at risk glycopyrronium Topical Wipes, Vehicle
Gastrointestinal disorders Dry Mouth	29.3% 68/232 • Up to 35 days 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.	7.6% 9/118 • Up to 35 days 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	7.3% 17/232 • Up to 35 days 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.	0.85% 1/118 • Up to 35 days 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	8.6% 20/232 • Up to 35 days 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.	9.3% 11/118 • Up to 35 days 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 Mydriasis	6.9% 16/232 • Up to 35 days 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% 0/118 • Up to 35 days 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	5.6% 13/232 • Up to 35 days 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.	1.7% 2/118 • Up to 35 days 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