Trial Outcomes & Findings for Study of Glycopyrronium in Axillary Hyperhydrosis (NCT NCT02530281)

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

344 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	229	115
Overall Study COMPLETED	208	112
Overall Study NOT COMPLETED	21	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Glycopyrronium in Axillary Hyperhydrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glycopyrronium n=229 Participants glycopyrronium Topical Wipes	Vehicle n=115 Participants glycopyrronium Topical Wipes, Vehicle	Total n=344 Participants Total of all reporting groups
Sex: Female, Male Male	99 Participants n=5 Participants	55 Participants n=7 Participants	154 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=5 Participants	23 Participants n=7 Participants	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	183 Participants n=5 Participants	92 Participants n=7 Participants	275 Participants n=5 Participants
Age, Categorical <=18 years	24 Participants n=5 Participants	10 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	204 Participants n=5 Participants	101 Participants n=7 Participants	305 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	130 Participants n=5 Participants	60 Participants n=7 Participants	190 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	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	31 Participants n=5 Participants	16 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) White	182 Participants n=5 Participants	94 Participants n=7 Participants	276 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	3 Participants n=7 Participants	13 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=229 Participants glycopyrronium Topical Wipes	Vehicle n=115 Participants glycopyrronium Topical Wipes, Vehicle
Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4	52.8 percent of subjects	28.3 percent of subjects

PRIMARY outcome

Timeframe: From Baseline to 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=229 Participants glycopyrronium Topical Wipes	Vehicle n=115 Participants glycopyrronium Topical Wipes, Vehicle
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4	-102.00 mg/5 min Standard Deviation 176.136	-100.34 mg/5 min Standard Deviation 172.276

PRIMARY outcome

Timeframe: From Baseline to Week 4

Population: Participant

Outcome measures

Outcome measures
Measure	Glycopyrronium n=229 Participants glycopyrronium Topical Wipes	Vehicle n=115 Participants glycopyrronium Topical Wipes, Vehicle
Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4	-80.79 mg/5 min Interval -148.78 to -40.15	-65.81 mg/5 min Interval -105.67 to -27.65

PRIMARY outcome

Timeframe: Baseline - Week 4

Population: Participant

Outcome measures

Outcome measures
Measure	Glycopyrronium n=220 Participants glycopyrronium Topical Wipes	Vehicle n=110 Participants glycopyrronium Topical Wipes, Vehicle
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data	-100.56 mg/5 min Standard Deviation 98.151	-88.08 mg/5 min Standard Deviation 95.695

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. 1 (Best), 2, 3, 4 (Worst)

Outcome measures

Outcome measures
Measure	Glycopyrronium n=229 Participants glycopyrronium Topical Wipes	Vehicle n=115 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	56.5 percent of subjects	23.7 percent of subjects

SECONDARY outcome

Timeframe: From Baseline to Week 4

Population: Participant

Outcome measures

Outcome measures
Measure	Glycopyrronium n=229 Participants glycopyrronium Topical Wipes	Vehicle n=115 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	72.4 percent of subjects	53.2 percent of subjects

Adverse Events

Glycopyrronium

Serious events: 1 serious events

Other events: 68 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Glycopyrronium n=227 participants at risk glycopyrronium Topical Wipes	Vehicle n=114 participants at risk glycopyrronium Topical Wipes, Vehicle
Eye disorders unilateral mydriasis	0.44% 1/227 • Number of events 1 • 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% 0/114 • 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=227 participants at risk glycopyrronium Topical Wipes	Vehicle n=114 participants at risk glycopyrronium Topical Wipes, Vehicle
Gastrointestinal disorders Dry Mouth	18.9% 43/227 • 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.	3.5% 4/114 • 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	8.8% 20/227 • 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.	9.6% 11/114 • 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 Pruritis	1.8% 4/227 • 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.	5.3% 6/114 • 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	6.2% 14/227 • 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% 0/114 • 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