Study of Glycopyrronium in Axillary Hyperhydrosis

Phase 3

Completed

• Conditions: Hyperhidrosis
• Interventions: Drug: glycopyrronium Topical Wipes; Other: Vehicle

• Registration Number: NCT02530281
• Lead Sponsor: Journey Medical Corporation

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.

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-21
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Disposition First Submitted: 2017-03-30
• Disposition First Submitted QC: 2017-03-30
• Disposition First Posted: 2017-04-04
• Results First Submitted: 2018-07-20
• Results First Submitted QC: 2018-07-20
• Results First Posted: 2018-08-14
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 344

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glycopyrronium	glycopyrronium Topical Wipes	glycopyrronium Topical Wipes
Vehicle	Vehicle	glycopyrronium Topical Wipes, Vehicle

Primary Outcome Measures

Name	Time	Method
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: 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)
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.
Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4	From Baseline to Week 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

Name	Time	Method
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)
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

Trial Locations

Locations (29)

Coastal Clinical Research, Inc.; 🇺🇸 Mobile, Alabama, United States

Skin Care Research, Inc.; 🇺🇸 Boca Raton, Florida, United States

Research Institute of the Southeast; 🇺🇸 West Palm Beach, Florida, United States

Rivergate Dermatology Clinical Research Center, PLLC; 🇺🇸 Goodlettsville, Tennessee, United States

International Dermatology Research, Inc.; 🇺🇸 Miami, Florida, United States

DermResearch; 🇺🇸 Austin, Texas, United States

Tory Sullivan, M.D., P.A.; 🇺🇸 North Miami Beach, Florida, United States

Klinik fur Dermatologie, Allergologie und Venerologie Allergie-Centrum-Charite; 🇩🇪 Berlin, Germany

St. Louis University Dermatology; 🇺🇸 Saint Louis, Missouri, United States

The Indiana Clinical Trials Center; 🇺🇸 Plainfield, Indiana, United States

J&S Studies; 🇺🇸 College Station, Texas, United States

Charlottesville Dermatology Research Center; 🇺🇸 Charlottesville, Virginia, United States

Tagesklinik DermaKiel; 🇩🇪 Kiel, Germany

Meridian Clinical Research; 🇺🇸 Omaha, Nebraska, United States

Austin Institute for Clinical Research; 🇺🇸 Pflugerville, Texas, United States

Dermatolosche Gemeinschaftspraxis; 🇩🇪 Mahlow, Germany

Hautarztpraxis; 🇩🇪 Stuttgart, Germany

Prairie Health and Wellness; 🇺🇸 Wichita, Kansas, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Texas Dermatology and Laser Specialists; 🇺🇸 San Antonio, Texas, United States

California Dermatology & Clinical Research Institute; 🇺🇸 Encinitas, California, United States

Study Protocol, Inc.; 🇺🇸 Boynton Beach, Florida, United States

Dermatology and Laser Center; 🇺🇸 Charleston, South Carolina, United States

ACRC Trials / Innovative Dermatology; 🇺🇸 Plano, Texas, United States

Pro DERMA im Hautzentrum Dulmen; 🇩🇪 Dülmen, Germany

SRH Wald-Klinikum Gera GmbH; 🇩🇪 Gera, Germany

Medical Practice and Derma Study Center Friedrichshafen GmbH; 🇩🇪 Friedrichshafen, Germany

Gemeinschaftspraxis Weber & Cranic; 🇩🇪 Schweinfurt, Germany

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States