Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

• Sponsor: Journey Medical Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02553798
• Collaborator: (none)
• Enrollment: 564
• Locations: 48
• Arm: 1
• Duration (Months): 16
• Patients Per Site: 11.8
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.

Condition or Disease	Intervention/Treatment	Phase
Hyperhidrosis	Drug: Glycopyrronium Topical Wipes	Phase 3

Detailed Description

Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.

Study Design

• Study Type: Interventional
• Actual Enrollment: 564 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glycopyrronium Glycopyrronium Topical Wipes	Drug: Glycopyrronium Topical Wipes; Glycopyrronium Topical Wipes; Other Names: DRM04

Outcome Measures

Primary Outcome Measures

1. Long-term Safety Assessed Through Adverse Events and Local Skin Reactions [Day 1 - Week 44]

   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 Outcome Measures

1. Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 [Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET]

   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.

2. Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) [Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET]

   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.

3. Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET [Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET]

   The Dermatology Life Quality Index DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance

• Male or females

Exclusion Criteria:

• Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated

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

• Any other condition which, in the judgement 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 Medical Research Group LLC	Mobile	Alabama	United States	36608
2	Northwest Arkansas Clinical Trials Center, PLLC	Rogers	Arkansas	United States	72758
3	California Dermatology & Clinical Research Institute	Encinitas	California	United States	92024
4	Dermatology Research Associates	Los Angeles	California	United States	90045
5	Therapeutics Clinical Research	San Diego	California	United States	92123
6	Clinical Science Institute	Santa Monica	California	United States	90404
7	Colorado Medical Research Center, Inc	Denver	Colorado	United States	80210
8	Skin Care Research, Inc.	Boca Raton	Florida	United States	33486
9	Study Protocol, Inc	Boynton Beach	Florida	United States	33437
10	International Dermatology Research, Inc.	Miami	Florida	United States	33144
11	Tory Sullivan, MD	North Miami Beach	Florida	United States	33162
12	Research Institute of the Southeast	West Palm Beach	Florida	United States	33401
13	Shideler Clinical Research Center	Carmel	Indiana	United States	46032
14	The Indiana Clinical Trials Center, PC	Plainfield	Indiana	United States	46168
15	Prairie Health and Wellness	Wichita	Kansas	United States	67206
16	Lawrence J. Green M.D., LLC	Rockville	Maryland	United States	20850
17	Zel Skin & Laser Specialist	Edina	Minnesota	United States	55424
18	MediSearch Clinical Trials	Saint Joseph	Missouri	United States	64506
19	St. Louis University Dermatology	Saint Louis	Missouri	United States	63122
20	Meridian Clinical Research	Omaha	Nebraska	United States	68134
21	Academic Dermatology Associates	Albuquerque	New Mexico	United States	87106-5239
22	Schweiger Dermatology Group	New York	New York	United States	10022
23	Skin Search of Rochester, Inc	Rochester	New York	United States	14623
24	Oregon Dermatology and Research Center	Portland	Oregon	United States	97210
25	Dermatology and Laser Center of Charleston, PA	Charleston	Pennsylvania	United States	29414
26	Rivergate Dermatology Research Center, PLLC	Goodlettsville	Tennessee	United States	37072
27	Clinical Research Associates, Inc	Nashville	Tennessee	United States	37203
28	DermResearch	Austin	Texas	United States	78759
29	J & S Studies, Inc.	College Station	Texas	United States	77845
30	Modern Research Associates, PLLC	Dallas	Texas	United States	75231
31	The University of Texas Dermatology Clinical Research Center	Houston	Texas	United States	77030
32	Austin Institute for Clinical Research	Pflugerville	Texas	United States	78860
33	ACRC Trials	Plano	Texas	United States	75024
34	Texas Dermatology and Laser Specialists	San Antonio	Texas	United States	78218
35	Dermatology Research Center, Inc.	Salt Lake City	Utah	United States	84117
36	Jordan Valley Dermatology Center, LLC	West Jordan	Utah	United States	84088
37	Charlottesville Medical Research	Charlottesville	Virginia	United States	22911
38	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23507
39	Dermatology Associates	Seattle	Washington	United States	98101
40	Premier Clinical Research	Spokane	Washington	United States	99202
41	Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité	Berlin		Germany	10117
42	Pro DERMA im Hautzentrum Dulmen	Dülmen		Germany	48249
43	Medical Practice and Derma-Study-Center Friedrichshafen GmbH	Friedrichshafen		Germany	88045
44	SRH Wald-Klinikum Gera GmbH	Gera		Germany	07548
45	Hautarztpraxis	Glückstadt		Germany	25348
46	Tagesklinik DermaKiel	Kiel		Germany	24148
47	Dermatolosche Gemeinschaftspraxis	Mahlow		Germany	15831
48	Gemeinschaftspraxis Weber & Cranic	Schweinfurt		Germany	97421

Sponsors and Collaborators

• Journey Medical Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Journey Medical Corporation
• ClinicalTrials.gov Identifier: NCT02553798
• Other Study ID Numbers: DRM04-HH06
• First Posted: Sep 18, 2015
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Additional relevant MeSH terms: Hyperhidrosis; Glycopyrrolate

Study Results

Participant Flow

Arm/Group Title	Glycopyrronium
Arm/Group Description	Glycopyrronium Topical Wipes
Period Title: Overall Study
STARTED	564
COMPLETED	226
NOT COMPLETED	338

Baseline Characteristics

Arm/Group Title	Glycopyrronium
Arm/Group Description	Glycopyrronium Topical Wipes
Overall Participants	564
Age (Count of Participants)
<=18 years	60 10.6%
Between 18 and 65 years	499 88.5%
>=65 years	5 0.9%
Sex: Female, Male (Count of Participants)
Female	309 54.8%
Male	255 45.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	97 17.2%
Not Hispanic or Latino	467 82.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.4%
Asian	3 0.5%
Native Hawaiian or Other Pacific Islander	1 0.2%
Black or African American	64 11.3%
White	470 83.3%
More than one race	24 4.3%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Long-term Safety Assessed Through Adverse Events and Local Skin Reactions
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.
Time Frame	Day 1 - Week 44

Outcome Measure Data

Analysis Population Description

Participant

Arm/Group Title	Glycopyrronium
Arm/Group Description	Glycopyrronium Topical Wipes
Measure Participants	550
Mild AEs	148
Moderate AEs	153
Severe AEs	28
Mild LSRs	120
Moderate LSRs	44
Severe LSRs	15

2. Other Pre-specified 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	Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET

Outcome Measure Data

Analysis Population Description

Participant

Arm/Group Title	Glycopyrronium
Arm/Group Description	Glycopyrronium Topical Wipes
Measure Participants	430
Mean (Standard Deviation) [mg/5 min]	-95.68 (140.806)

3. Other Pre-specified Outcome

Title	Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS)
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.
Time Frame	Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET

Outcome Measure Data

Analysis Population Description

Participant

Arm/Group Title	Glycopyrronium
Arm/Group Description	Glycopyrronium Topical Wipes
Measure Participants	437
3 - point improvement	72 12.8%
2 - point improvement	204 36.2%
1 - point improvement	135 23.9%
no improvement	26 4.6%

4. Other Pre-specified Outcome

Title	Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET
Description	The Dermatology Life Quality Index DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.
Time Frame	Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET

Outcome Measure Data

Analysis Population Description

Participant

Arm/Group Title	Glycopyrronium
Arm/Group Description	Glycopyrronium Topical Wipes
Measure Participants	406
Mean (Standard Deviation) [scores on a scale]	-8.7 (6.24)

Adverse Events

Time Frame	up to 45 weeks
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
Arm/Group Description	Glycopyrronium Topical Wipes Glycopyrronium Topical Wipes: Glycopyrronium Topical Wipes
All Cause Mortality
	Glycopyrronium
	Affected / at Risk (%)	# Events
Total	0/550 (0%)
Serious Adverse Events
	Glycopyrronium
	Affected / at Risk (%)	# Events
Total	7/550 (1.3%)
Eye disorders
Mydriasis	1/550 (0.2%)
General disorders
Chest pain	1/550 (0.2%)
Infections and infestations
Diverticulitis	1/550 (0.2%)
Infectious colitis	1/550 (0.2%)
Injury, poisoning and procedural complications
Concussion	1/550 (0.2%)
Psychiatric disorders
Affective disorder	1/550 (0.2%)
Suicide attempt	1/550 (0.2%)
Other (Not Including Serious) Adverse Events
	Glycopyrronium
	Affected / at Risk (%)	# Events
Total	178/550 (32.4%)
Eye disorders
Vision blurred	37/550 (6.7%)
Mydriasis	28/550 (5.1%)
Gastrointestinal disorders
Dry Mouth	93/550 (16.9%)
General disorders
Application Site Pain	35/550 (6.4%)
Infections and infestations
Nasopharyngitis	32/550 (5.8%)

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.