Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis

• Sponsor: Dermira, Inc.
• Information provided by (Responsible Party): Dermira, Inc.

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	353 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 Hyperhidrosis
Study Start Date :	August 2015
Actual Primary Completion Date :	April 2016
Actual Study Completion Date :	April 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: glycopyrronium; glycopyrronium Topical Wipes	Drug: glycopyrronium Topical Wipes; Topical wipes containing glycopyrronium; Other Name: 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 Axillary Sweating Daily Diary (ASDD) Item #2 From Baseline at Week 4 [ Time Frame: 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:

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

Eligibility Criteria

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Ages Eligible for Study:	9 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

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United States, Arkansas
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, United States, 72758
United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
Clinical Science Institute
Santa Monica, California, United States, 90404
United States, Colorado
Colorado Medical Research Center, Inc.
Denver, Colorado, United States, 80210
United States, Indiana
Shideler Clinical Research Center
Carmel, Indiana, United States, 46032
United States, Maryland
Lawrence J Green, MD LLC
Rockville, Maryland, United States, 20850
United States, Minnesota
Zel Skin & Laser Specialist
Edina, Minnesota, United States, 55424
United States, Missouri
MediSearch Clinical Trials
Saint Joseph, Missouri, United States, 64506
United States, Nevada
Clinical Studies Group, LLC
Henderson, Nevada, United States, 89044
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
Schweiger Dermatology Group
New York, New York, United States, 10022
Skin Search of Rochester, Inc.
Rochester, New York, United States, 14623
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
United States, Tennessee
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
Modern Research Associates
Dallas, Texas, United States, 75231
The University of Texas Dermatology Clinical Research Center
Houston, Texas, United States, 77030
United States, Utah
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States, 84117
Jordan Valley Dermatology Center
West Jordan, Utah, United States, 84088
United States, Washington
Dermatology Associates
Seattle, Washington, United States, 98101
Premier Clinical Research
Spokane, Washington, United States, 99202

Sponsors and Collaborators

Dermira, Inc.

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pariser DM, Hebert AA, Drew J, Quiring J, Gopalan R, Glaser DA. Topical Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Patient-Reported Outcomes from the ATMOS-1 and ATMOS-2 Phase III Randomized Controlled Trials. Am J Clin Dermatol. 2019 Feb;20(1):135-145. doi: 10.1007/s40257-018-0395-0.

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Responsible Party:	Dermira, Inc.
ClinicalTrials.gov Identifier:	NCT02530294 History of Changes
Other Study ID Numbers:	DRM04-HH05; 2015-002053-35 ( EudraCT Number )
First Posted:	August 21, 2015
Results First Posted:	August 14, 2018
Last Update Posted:	September 25, 2018
Last Verified:	August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:

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Hyperhidrosis; Sweat Gland Diseases; Skin Diseases