A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis

• Sponsor: Journey Medical Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03880266
• Collaborator: (none)
• Enrollment: 72
• Locations: 7
• Arms: 8
• Actual Duration (Months): 3
• Patients Per Site: 10.3
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.

Condition or Disease	Intervention/Treatment	Phase
Palmar Hyperhidrosis	Drug: Glycopyrronium cloth, 2.4%; Drug: Vehicle	Phase 2

Detailed Description

This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
• Actual Study Start Date: Feb 22, 2019
• Actual Primary Completion Date: May 24, 2019
• Actual Study Completion Date: May 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 Active Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Drug: Glycopyrronium cloth, 2.4%; Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium
Placebo Comparator: Group 1 Vehicle Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Drug: Vehicle; Pre-saturated 100% polypropylene, nonwoven, fabric cloth
Active Comparator: Group 2 Active Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Drug: Glycopyrronium cloth, 2.4%; Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium
Placebo Comparator: Group 2 Vehicle Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Drug: Vehicle; Pre-saturated 100% polypropylene, nonwoven, fabric cloth
Active Comparator: Group 3 Active Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes	Drug: Glycopyrronium cloth, 2.4%; Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium
Placebo Comparator: Group 3 Vehicle Vehicle cloth applied to the hands once daily for 14 days: 15 minutes	Drug: Vehicle; Pre-saturated 100% polypropylene, nonwoven, fabric cloth
Active Comparator: Group 4 Active Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes	Drug: Glycopyrronium cloth, 2.4%; Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium
Placebo Comparator: Group 4 Vehicle Vehicle cloth applied to the hands once daily for 14 days: 30 minutes	Drug: Vehicle; Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline to Week 2 in Hand Sweating Severity Score [Baseline, Week 2]

   The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis [score on a scale from 0 (better) -10 (worse)].

Secondary Outcome Measures

1. Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 [Baseline, Week 2]

   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 (better), 2, 3, 4 (worse)

2. Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 [Baseline, Week 2]

   Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; average of the change in the gravimetric measurement of sweat produced at baseline compared with Week 2

3. Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 [Baseline, Week 2]

   Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; calculation of percentage difference in sweat production at week 2 compared to baseline sweat production

4. Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 [Baseline, Week 2]

   Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; confidence interval represents difference between vehicle and active group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Signed informed consent and assent (for subjects under legal adult age).

2. Age ≥9 years.

3. Primary palmar hyperhidrosis for at least 6 months duration.

4. Average sweat severity score of ≥4 at Baseline.

5. Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline.

6. Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol.

7. Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females.

Exclusion Criteria:

1. Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%.

2. Prior surgical procedure for hyperhidrosis.

3. Iontophoresis for the palms within 4 weeks of Baseline.

4. Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline.

5. Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.

6. Secondary palmar hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism).

7. Known history of Sjögren's syndrome or Sicca syndrome.

8. History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis.

9. Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Dermatology & Clinical Research Institute	Encinitas	California	United States	92024
2	Colorado Medical Research Center, Inc.	Denver	Colorado	United States	80210
3	International Dermatology Research, Inc.	Miami	Florida	United States	33144
4	The Indiana Clinical Trials Center	Plainfield	Indiana	United States	46168
5	Saint Louis University Dermatology	Saint Louis	Missouri	United States	63122
6	Innovative Dermatology/ ACRC Trials	Plano	Texas	United States	75024
7	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23502

Sponsors and Collaborators

• Journey Medical Corporation

Investigators

• Study Director: Kate Doherty, Dermira, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 11, 2018

More Information

Publications

None provided.

• Responsible Party: Journey Medical Corporation
• ClinicalTrials.gov Identifier: NCT03880266
• Other Study ID Numbers: DRM04-HH10
• First Posted: Mar 19, 2019
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperhidrosis; Glycopyrrolate

Study Results

Participant Flow

Arm/Group Title	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
Arm/Group Description	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
Period Title: Overall Study
STARTED	12	6	12	4	12	6	13	7
COMPLETED	12	5	11	4	12	6	13	7
NOT COMPLETED	0	1	1	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle	Total
Arm/Group Description	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Vehicle applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Vehicle applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes	Vehicle applied to the hands once daily for 14 days: 15 minutes	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes	Vehicle applied to the hands once daily for 14 days: 30 minutes	Total of all reporting groups
Overall Participants	12	6	12	4	12	6	13	7	72
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.2 (8.95)	34.5 (15.93)	29.2 (11.57)	47.5 (17.56)	28.2 (12.45)	32.5 (7.97)	26.6 (9.54)	37.1 (13.91)	31.1 (12.27)
Sex: Female, Male (Count of Participants)
Female	8 66.7%	4 66.7%	7 58.3%	4 100%	8 66.7%	3 50%	8 61.5%	5 71.4%	47 65.3%
Male	4 33.3%	2 33.3%	5 41.7%	0 0%	4 33.3%	3 50%	5 38.5%	2 28.6%	25 34.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.4%
Asian	1 8.3%	0 0%	1 8.3%	0 0%	0 0%	1 16.7%	0 0%	0 0%	3 4.2%
Native Hawaiian or Other Pacific Islander	1 8.3%	1 16.7%	2 16.7%	0 0%	1 8.3%	0 0%	1 7.7%	2 28.6%	8 11.1%
Black or African American	1 8.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.4%
White	8 66.7%	4 66.7%	7 58.3%	4 100%	9 75%	4 66.7%	12 92.3%	5 71.4%	53 73.6%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 8.3%	0 0%	2 16.7%	0 0%	2 16.7%	1 16.7%	0 0%	0 0%	6 8.3%
Region of Enrollment (participants) [Number]
United States	12 100%	6 100%	12 100%	4 100%	12 100%	6 100%	13 100%	7 100%	72 100%
Hand Sweat Severity Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.78 (1.646)	7.40 (0.718)	7.56 (1.450)	8.10 (1.920)	6.93 (1.689)	7.37 (2.017)	7.58 (1.399)	8.01 (1.078)	7.37 (1.51)

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
Description	The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis [score on a scale from 0 (better) -10 (worse)].
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
Arm/Group Description	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
Measure Participants	12	5	11	4	12	6	13	7
Mean (Standard Deviation) [score on a scale]	-2.14 (2.199)	-0.56 (0.730)	-1.64 (1.410)	-3.03 (2.161)	-2.53 (2.223)	-2.20 (1.084)	-1.30 (2.062)	-1.34 (1.909)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 Active, Group 1 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.244
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.58
	Confidence Interval	(2-Sided) 95%; -3.76 to 0.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2 Active, Group 2 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.168
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.39
	Confidence Interval	(2-Sided) 95%; -0.65 to 3.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3 Active, Group 3 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.699
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95%; -2.39 to 1.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Group 4 Active, Group 4 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.833
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -1.94 to 2.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2
Description	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 (better), 2, 3, 4 (worse)
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
Arm/Group Description	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
Measure Participants	12	5	10	4	11	6	13	7
Count of Participants [Participants]	3 25%	0 0%	1 8.3%	2 50%	1 8.3%	2 33.3%	3 23.1%	2 28.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 Active, Group 1 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.000
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2 Active, Group 2 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.589
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3 Active, Group 3 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.154
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Group 4 Active, Group 4 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.646
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Description	Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; average of the change in the gravimetric measurement of sweat produced at baseline compared with Week 2
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
Arm/Group Description	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
Measure Participants	12	5	11	4	12	6	13	7
Mean (Standard Deviation) [mg]	-69.8 (162.54)	136.7 (320.57)	-15.3 (53.14)	-159.4 (354.38)	-113.5 (164.10)	38.1 (106.30)	-58.6 (139.70)	102.0 (767.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 Active, Group 1 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.093
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-206.5
	Confidence Interval	(2-Sided) 95%; -451.9 to 38.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2 Active, Group 2 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.186
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	144.1
	Confidence Interval	(2-Sided) 95%; -78.6 to 366.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3 Active, Group 3 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.058
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-151.7
	Confidence Interval	(2-Sided) 95%; -309.0 to 5.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Group 4 Active, Group 4 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.186
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	160.6
	Confidence Interval	(2-Sided) 95%; -611.2 to 290.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Description	Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; calculation of percentage difference in sweat production at week 2 compared to baseline sweat production
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
Arm/Group Description	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
Measure Participants	12	5	11	4	12	6	13	7
Mean (Standard Deviation) [Percent change]	-17.1 (28.26)	16.5 (60.4)	-7.5 (65.53)	-31.8 (51.29)	-26.8 (39.17)	11.4 (34.96)	-17.7 (40.43)	21.7 (145.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 Active, Group 1 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.130
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-33.62
	Confidence Interval	(2-Sided) 95%; -78.42 to 11.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2 Active, Group 2 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.518
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	24.26
	Confidence Interval	(2-Sided) 95%; -54.62 to 103.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3 Active, Group 3 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.061
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-38.14
	Confidence Interval	(2-Sided) 95%; -78.32 to 2.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Group 4 Active, Group 4 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.366
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-39.34
	Confidence Interval	(2-Sided) 95%; -128.40 to 49.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2
Description	Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; confidence interval represents difference between vehicle and active group
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
Arm/Group Description	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
Measure Participants	12	5	11	4	12	6	13	7
Count of Participants [Participants]	1 8.3%	1 16.7%	3 25%	2 50%	4 33.3%	0 0%	2 15.4%	3 42.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 Active, Group 1 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.515
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2 Active, Group 2 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.560
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3 Active, Group 3 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.245
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Group 4 Active, Group 4 Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.290
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Time Frame	Baseline through Week 2
Adverse Event Reporting Description	All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
Arm/Group Title	Group 1 Active		Group 1 Vehicle		Group 2 Active		Group 2 Vehicle		Group 3 Active		Group 3 Vehicle		Group 4 Active		Group 4 Vehicle
Arm/Group Description	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)		Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)		Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)		Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)		Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes		Vehicle cloth applied to the hands once daily for 14 days: 15 minutes		Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes		Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
All Cause Mortality
	Group 1 Active		Group 1 Vehicle		Group 2 Active		Group 2 Vehicle		Group 3 Active		Group 3 Vehicle		Group 4 Active		Group 4 Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/6 (0%)		0/12 (0%)		0/4 (0%)		0/12 (0%)		0/6 (0%)		0/13 (0%)		0/7 (0%)
Serious Adverse Events
	Group 1 Active		Group 1 Vehicle		Group 2 Active		Group 2 Vehicle		Group 3 Active		Group 3 Vehicle		Group 4 Active		Group 4 Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/6 (0%)		0/12 (0%)		0/4 (0%)		0/12 (0%)		0/6 (0%)		0/13 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Group 1 Active		Group 1 Vehicle		Group 2 Active		Group 2 Vehicle		Group 3 Active		Group 3 Vehicle		Group 4 Active		Group 4 Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/12 (41.7%)		2/6 (33.3%)		5/12 (41.7%)		1/4 (25%)		1/12 (8.3%)		2/6 (33.3%)		2/13 (15.4%)		0/7 (0%)
Eye disorders
Dry eye	1/12 (8.3%)	1	0/6 (0%)	0	0/12 (0%)	0	0/4 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/13 (0%)	0	0/7 (0%)	0
Photophobia	1/12 (8.3%)	1	0/6 (0%)	0	0/12 (0%)	0	0/4 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/13 (0%)	0	0/7 (0%)	0
Gastrointestinal disorders
Dry Mouth	1/12 (8.3%)	1	1/6 (16.7%)	1	2/12 (16.7%)	2	0/4 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/13 (0%)	0	0/7 (0%)	0
Abdominal pain upper	0/12 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/4 (0%)	0	0/12 (0%)	0	1/6 (16.7%)	1	0/13 (0%)	0	0/7 (0%)	0
Stomatitis	0/12 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	1/4 (25%)	1	0/12 (0%)	0	0/6 (0%)	0	0/13 (0%)	0	0/7 (0%)	0
General disorders
Application site pruritus	0/12 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/4 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	1/13 (7.7%)	1	0/7 (0%)	0
Infections and infestations
Viral upper respiratory tract infection	0/12 (0%)	0	0/6 (0%)	0	1/12 (8.3%)	1	0/4 (0%)	0	0/12 (0%)	0	1/6 (16.7%)	1	0/13 (0%)	0	0/7 (0%)	0
Influenza	1/12 (8.3%)	1	0/6 (0%)	0	0/12 (0%)	0	0/4 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/13 (0%)	0	0/7 (0%)	0
Nasopharyngitis	0/12 (0%)	0	0/6 (0%)	0	1/12 (8.3%)	1	0/4 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/13 (0%)	0	0/7 (0%)	0
Injury, poisoning and procedural complications
Compensatory sweating	1/12 (8.3%)	1	0/6 (0%)	0	1/12 (8.3%)	1	0/4 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/13 (0%)	0	0/7 (0%)	0
Thermal burn	0/12 (0%)	0	1/6 (16.7%)	1	0/12 (0%)	0	0/4 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/13 (0%)	0	0/7 (0%)	0
Investigations
White blood cell count increased	0/12 (0%)	0	0/6 (0%)	0	1/12 (8.3%)	1	0/4 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/13 (0%)	0	0/7 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness	0/12 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/4 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	1/13 (7.7%)	1	0/7 (0%)	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/12 (8.3%)	1	0/6 (0%)	0	0/12 (0%)	0	0/4 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/13 (0%)	0	0/7 (0%)	0
Rhinitis allergic	0/12 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/4 (0%)	0	1/12 (8.3%)	1	0/6 (0%)	0	0/13 (0%)	0	0/7 (0%)	0
Skin and subcutaneous tissue disorders
Dry skin	1/12 (8.3%)	1	0/6 (0%)	0	0/12 (0%)	0	0/4 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/13 (0%)	0	0/7 (0%)	0
Skin exfoliation	0/12 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/4 (0%)	0	0/12 (0%)	0	1/6 (16.7%)	1	0/13 (0%)	0	0/7 (0%)	0

Limitations/Caveats

Small sample size

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.