Trial Outcomes & Findings for Qbrexza Cloths for Hyperhidrosis of Amputation Sites (NCT NCT04924036)
NCT ID: NCT04924036
Last Updated: 2026-01-22
Results Overview
ASDD-m is a questionnaire for axillary hyperhidrosis measuring for presence, severity, impact and bothersomeness of the patient's sweating. Question #1 is "Rate the Sweating at its worst" that a patient rates from 0-10 (0 meaning no sweating at all, and 10 meaning worst possible sweating). This single score was used from the number of responses listed below while patient was on active drug, and while they were on placebo. Patients completed this questionnaire daily throughout the study (4 weeks of glycopyrronium cloths, 1 week of washout, and 4 weeks of placebo). Therefore, each patient could have up to 28 entries, however, some patients ended the study early, and some missed a few surveys.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
4 weeks
Results posted on
2026-01-22
Participant Flow
Participant milestones
| Measure |
Glycopyrronium Cloths, Then Placebo
Participants Randomized Glycopyrronium Cloths, then Placebo.
Participants first received glycopyronium cloths for 4 weeks, then a 1 week washout period, and then 4 weeks of placebo.
glycopyrronium cloths: Qbrexza is an anticholinergic indicated for topical treatment of axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
|
Placebo, Then Glycopyrronium Cloths
Participants were randomized to placebo cloths for 4 weeks, then a 1-week washout period, and then 4 weeks with the glycopyrronium cloths.
Placebo: Placebo for this study are cloths that look like the glycopyrronium cloths but do not have any active ingredient.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Qbrexza Cloths for Hyperhidrosis of Amputation Sites
Baseline characteristics by cohort
| Measure |
Glycopyrronium Cloths Then Placebo
n=7 Participants
Participants that are randomized to Glycopyrronium cloths for 4 weeks, then 2 week wash out, then cross over to placebo cloths for 4 weeks.
glycopyrronium cloths: Qbrexza is an anticholinergic indicated for topical treatment of axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
Placebo: Placebo for this study are cloths that look like the qbrexza cloths but do not have any active ingredient.
|
Placebo Then Glycopyrronium Cloths
n=6 Participants
Participants that are randomized to placebo cloths for 4 weeks, then 2 week wash out, then cross over to Glycopyrronium cloths for 4 weeks.
glycopyrronium cloths: Qbrexza is an anticholinergic indicated for topical treatment of axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
Placebo: Placebo for this study are cloths that look like the qbrexza cloths but do not have any active ingredient.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=270 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 14.9 • n=270 Participants
|
43.6 years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
43.5 years
STANDARD_DEVIATION 14.5 • n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=270 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=270 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=270 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Patients completed this questionnaire daily throughout the study (4 weeks of active drug, 1 week washout, 4 weeks of placebo).
ASDD-m is a questionnaire for axillary hyperhidrosis measuring for presence, severity, impact and bothersomeness of the patient's sweating. Question #1 is "Rate the Sweating at its worst" that a patient rates from 0-10 (0 meaning no sweating at all, and 10 meaning worst possible sweating). This single score was used from the number of responses listed below while patient was on active drug, and while they were on placebo. Patients completed this questionnaire daily throughout the study (4 weeks of glycopyrronium cloths, 1 week of washout, and 4 weeks of placebo). Therefore, each patient could have up to 28 entries, however, some patients ended the study early, and some missed a few surveys.
Outcome measures
| Measure |
Glycopyrronium Cloths
n=210 Each survey response score
Patients who received glycopyrronium cloths (either in the first 4 weeks or last 4 weeks of the study).
|
Placebo
n=198 Each survey response score
Participants that received placebo cloths either in the first 4 weeks or last 4 weeks of the study.
|
|---|---|---|
|
ASDD-m Sweat Severity Score
|
1.2 score on a scale of 0-10
Standard Deviation 2.0
|
3.6 score on a scale of 0-10
Standard Deviation 2.9
|
Adverse Events
Glycopyrronium Cloths
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Glycopyrronium Cloths
n=13 participants at risk
Participants Randomized to glycopyrronium cloths.
glycopyrronium cloths: Qbrexza is an anticholinergic indicated for topical treatment of axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
|
Placebo
n=13 participants at risk
Participants that are randomized to placebo cloths.
Placebo: Placebo for this study are cloths that look like the qbrexza cloths but do not have any active ingredient.
|
|---|---|---|
|
Renal and urinary disorders
Urinary Retention
|
7.7%
1/13 • Number of events 1 • 17 months
|
0.00%
0/13 • 17 months
|
Other adverse events
| Measure |
Glycopyrronium Cloths
n=13 participants at risk
Participants Randomized to glycopyrronium cloths.
glycopyrronium cloths: Qbrexza is an anticholinergic indicated for topical treatment of axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
|
Placebo
n=13 participants at risk
Participants that are randomized to placebo cloths.
Placebo: Placebo for this study are cloths that look like the qbrexza cloths but do not have any active ingredient.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Lupus Flare
|
0.00%
0/13 • 17 months
|
7.7%
1/13 • Number of events 1 • 17 months
|
|
General disorders
Dry Mouth
|
15.4%
2/13 • Number of events 2 • 17 months
|
0.00%
0/13 • 17 months
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
15.4%
2/13 • Number of events 2 • 17 months
|
15.4%
2/13 • Number of events 2 • 17 months
|
|
Skin and subcutaneous tissue disorders
Anhidrosis
|
7.7%
1/13 • Number of events 1 • 17 months
|
0.00%
0/13 • 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbated asthma
|
7.7%
1/13 • Number of events 1 • 17 months
|
0.00%
0/13 • 17 months
|
|
Skin and subcutaneous tissue disorders
Irritant contact dermatitis
|
7.7%
1/13 • Number of events 1 • 17 months
|
7.7%
1/13 • Number of events 1 • 17 months
|
|
Skin and subcutaneous tissue disorders
cyst
|
7.7%
1/13 • Number of events 1 • 17 months
|
0.00%
0/13 • 17 months
|
|
Nervous system disorders
vertigo
|
0.00%
0/13 • 17 months
|
7.7%
1/13 • Number of events 1 • 17 months
|
|
General disorders
generalized fatigue
|
0.00%
0/13 • 17 months
|
7.7%
1/13 • Number of events 1 • 17 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place