Study of Glycopyrronium in Axillary Hyperhydrosis

• Sponsor: Journey Medical Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02530281
• Collaborator: (none)
• Enrollment: 344
• Locations: 31
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 11.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The study is a randomized, double-blind, vehicle controlled, parallel group study, designed to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to vehicle in subjects with axillary hyperhidrosis.

Condition or Disease	Intervention/Treatment	Phase
Hyperhidrosis	Drug: glycopyrronium Topical Wipes; Other: Vehicle	Phase 3

Detailed Description

This is a randomized, double-blind vehicle controlled study to assess the efficacy and safety of glycopyrronium topical wipes compared to vehicle in subjects with axillary hyperhidrosis.

Safety will be assessed through lab tests, ECG, physical exams and vital signs.

Study Design

• Study Type: Interventional
• Actual Enrollment: 344 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhydrosis
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: glycopyrronium glycopyrronium Topical Wipes	Drug: glycopyrronium Topical Wipes; Topical wipes containing glycopyrronium; Other Names: DRM04
Placebo Comparator: Vehicle glycopyrronium Topical Wipes, Vehicle	Other: Vehicle; Vehicle (placebo) topical wipes

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4 [From Baseline to Week 4]

   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: During the past 24 hours, did you have any underarm sweating? (Yes or No) 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) 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) 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)

2. Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 [From Baseline to Week 4]

   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.

3. Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 [From Baseline to Week 4]

4. Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data [Baseline - Week 4]

Secondary Outcome Measures

1. Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4 [From Baseline to Week 4]

   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)

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

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male or female ≥ 9 years of age.

• Primary, axillary hyperhidrosis of at least 6 months duration

• Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline

• Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline

• Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically

Exclusion Criteria:

• Prior surgical procedure for hyperhidrosis.

• Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational).

• Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.

• Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.

• Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline.

• Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline.

• Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months.

• Other treatment with glycopyrrolate within 4 weeks prior to Baseline.

• Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis.

• History of Sjögren's syndrome or Sicca syndrome.

• History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.

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

• History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter.

• Other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Clinical Research, Inc.	Mobile	Alabama	United States	36608
2	California Dermatology & Clinical Research Institute	Encinitas	California	United States	92024
3	Therapeutics Clinical Research	San Diego	California	United States	92123
4	Skin Care Research, Inc.	Boca Raton	Florida	United States	33486
5	Study Protocol, Inc.	Boynton Beach	Florida	United States	33437
6	International Dermatology Research, Inc.	Miami	Florida	United States	33144
7	Tory Sullivan, M.D., P.A.	North Miami Beach	Florida	United States	33162
8	Research Institute of the Southeast	West Palm Beach	Florida	United States	33401
9	The Indiana Clinical Trials Center	Plainfield	Indiana	United States	46168
10	Prairie Health and Wellness	Wichita	Kansas	United States	67226
11	St. Louis University Dermatology	Saint Louis	Missouri	United States	63122
12	Meridian Clinical Research	Omaha	Nebraska	United States	68134
13	Dermatology and Laser Center	Charleston	South Carolina	United States	29414
14	Rivergate Dermatology Clinical Research Center, PLLC	Goodlettsville	Tennessee	United States	37072
15	DermResearch	Austin	Texas	United States	78759
16	J&S Studies	College Station	Texas	United States	77845
17	Austin Institute for Clinical Research	Pflugerville	Texas	United States	78860
18	ACRC Trials / Innovative Dermatology	Plano	Texas	United States	75024
19	Texas Dermatology and Laser Specialists	San Antonio	Texas	United States	78218
20	Charlottesville Dermatology Research Center	Charlottesville	Virginia	United States	22911
21	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23507
22	Klinik fur Dermatologie, Allergologie und Venerologie Allergie-Centrum-Charite	Berlin		Germany	10117
23	Pro DERMA im Hautzentrum Dulmen	Dülmen		Germany	48249
24	Medical Practice and Derma Study Center Friedrichshafen GmbH	Friedrichshafen		Germany	88045
25	SRH Wald-Klinikum Gera GmbH	Gera		Germany	07548
26	Hautarztpraxis	Glückstadt		Germany	25348
27	Tagesklinik DermaKiel	Kiel		Germany	24148
28	Dermatolosche Gemeinschaftspraxis	Mahlow		Germany	15831
29	Hautarztpraxis	Pinneberg		Germany	25421
30	Gemeinschaftspraxis Weber & Cranic	Schweinfurt		Germany	97421
31	Hautarztpraxis	Stuttgart		Germany	70499

Sponsors and Collaborators

• Journey Medical Corporation

Investigators

• Study Director: Lynne M Deans, MT, Dermira, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Journey Medical Corporation
• ClinicalTrials.gov Identifier: NCT02530281
• Other Study ID Numbers: DRM04-HH04; 2015-002052-27
• First Posted: Aug 21, 2015
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Hyperhidrosis; Glycopyrrolate

Study Results

Participant Flow

Arm/Group Title	Glycopyrronium	Vehicle
Arm/Group Description	Glycopyrronium Topical Wipes	Glycopyrronium Topical Wipes, Vehicle
Period Title: Overall Study
STARTED	229	115
COMPLETED	208	112
NOT COMPLETED	21	3

Baseline Characteristics

Arm/Group Title	Glycopyrronium	Vehicle	Total
Arm/Group Description	glycopyrronium Topical Wipes	glycopyrronium Topical Wipes, Vehicle	Total of all reporting groups
Overall Participants	229	115	344
Age (Count of Participants)
<=18 years	24 10.5%	10 8.7%	34 9.9%
Between 18 and 65 years	204 89.1%	101 87.8%	305 88.7%
>=65 years	1 0.4%	4 3.5%	5 1.5%
Sex: Female, Male (Count of Participants)
Female	130 56.8%	60 52.2%	190 55.2%
Male	99 43.2%	55 47.8%	154 44.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	46 20.1%	23 20%	69 20.1%
Not Hispanic or Latino	183 79.9%	92 80%	275 79.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.9%	0 0%	2 0.6%
Asian	4 1.7%	0 0%	4 1.2%
Native Hawaiian or Other Pacific Islander	0 0%	2 1.7%	2 0.6%
Black or African American	31 13.5%	16 13.9%	47 13.7%
White	182 79.5%	94 81.7%	276 80.2%
More than one race	10 4.4%	3 2.6%	13 3.8%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4
Description	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: During the past 24 hours, did you have any underarm sweating? (Yes or No) 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) 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) 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)
Time Frame	From Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Participant

Arm/Group Title	Glycopyrronium	Vehicle
Arm/Group Description	glycopyrronium Topical Wipes	glycopyrronium Topical Wipes, Vehicle
Measure Participants	229	115
Number [percent of subjects]	52.8	28.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glycopyrronium, Vehicle
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

2. Primary Outcome

Title	Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Description	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.
Time Frame	From Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Participant

Arm/Group Title	Glycopyrronium	Vehicle
Arm/Group Description	glycopyrronium Topical Wipes	glycopyrronium Topical Wipes, Vehicle
Measure Participants	229	115
Least Squares Mean (Standard Deviation) [mg/5 min]	-102.00 (176.136)	-100.34 (172.276)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glycopyrronium, Vehicle
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.065
	Comments
	Method	ANCOVA
	Comments	Ranked ANCOVA

3. Primary Outcome

Title	Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Time Frame	From Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Participant

Arm/Group Title	Glycopyrronium	Vehicle
Arm/Group Description	glycopyrronium Topical Wipes	glycopyrronium Topical Wipes, Vehicle
Measure Participants	229	115
Median (Inter-Quartile Range) [mg/5 min]	-80.79	-65.81

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glycopyrronium, Vehicle
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.065
	Comments
	Method	ANCOVA
	Comments	Ranked ANCOVA

4. Primary Outcome

Title	Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data
Time Frame	Baseline - Week 4

Outcome Measure Data

Analysis Population Description

Participant

Arm/Group Title	Glycopyrronium	Vehicle
Arm/Group Description	Glycopyrronium Topical Wipes	Glycopyrronium Topical Wipes, Vehicle
Measure Participants	220	110
Least Squares Mean (Standard Deviation) [mg/5 min]	-100.56 (98.151)	-88.08 (95.695)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glycopyrronium, Vehicle
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.001
	Comments
	Method	ANCOVA
	Comments	Ranked ANCOVA

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant

Arm/Group Title	Glycopyrronium	Vehicle
Arm/Group Description	glycopyrronium Topical Wipes	glycopyrronium Topical Wipes, Vehicle
Measure Participants	229	115
Number [percent of subjects]	56.5	23.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glycopyrronium, Vehicle
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

6. Secondary Outcome

Title	Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Time Frame	From Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Participant

Arm/Group Title	Glycopyrronium	Vehicle
Arm/Group Description	glycopyrronium Topical Wipes	glycopyrronium Topical Wipes, Vehicle
Measure Participants	229	115
Number [percent of subjects]	72.4	53.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glycopyrronium, Vehicle
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Adverse Events

Time Frame	up to 35 days
Adverse Event Reporting Description	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.
Arm/Group Title	Glycopyrronium		Vehicle
Arm/Group Description	glycopyrronium Topical Wipes		glycopyrronium Topical Wipes, Vehicle
All Cause Mortality
	Glycopyrronium		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/227 (0%)		0/114 (0%)
Serious Adverse Events
	Glycopyrronium		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/227 (0.4%)		0/114 (0%)
Eye disorders
unilateral mydriasis	1/227 (0.4%)	1	0/114 (0%)	0
Other (Not Including Serious) Adverse Events
	Glycopyrronium		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	68/227 (30%)		16/114 (14%)
Eye disorders
Mydriasis	14/227 (6.2%)		0/114 (0%)
Gastrointestinal disorders
Dry Mouth	43/227 (18.9%)		4/114 (3.5%)
General disorders
Application Site Pain	20/227 (8.8%)		11/114 (9.6%)
Application Site Pruritis	4/227 (1.8%)		6/114 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.