Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis

• ClinicalTrials.gov Identifier: NCT02129660
• Recruitment Status: Completed
• First Posted: May 2, 2014
• Results First Posted: September 4, 2018
• Last Update Posted: September 4, 2018
• Sponsor: Dermira, Inc.
• Information provided by (Responsible Party): Dermira, Inc.

Study Description

Brief Summary:

The purpose of the study is to assess the safety of 2 doses of glycopyrrolate compared to 2 doses of glycopyrronium and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied once daily for 4 weeks followed by a 2-week post-dose period.

Condition or disease	Intervention/treatment	Phase
Hyperhidrosis	Drug: Dose 1 of glycopyrrolate, 2.0% QD; Drug: Dose 2 of glycopyrrolate, 3.0% QD; Drug: Dose 1 of glycopyrronium, 2.5% QD; Drug: Dose 2 of glycopyrronium, 3.75% QD; Other: Vehicle	Phase 2

Detailed Description:

This is a randomized, double-blind, vehicle controlled, parallel group, comparator study designed to assess the safety, efficacy and pharmacokinetics of two doses of glycopyrrolate compared to two doses of glycopyrronium compared to vehicle, 5 treatment arms.

Efficacy will be assessed through gravimetric assessment of sweat production using Patient Reported Outcome and the Hyperhidrosis Disease Severity Score (HDSS).

Safety will be assessed through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK blood samples will be taken study subjects.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Double-Blind Vehicle-Controlled Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis
• Study Start Date: April 2014
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: January 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dose 1 of glycopyrrolate, 2.0% QD; glycopyrrolate Topical Wipes	Drug: Dose 1 of glycopyrrolate, 2.0% QD; Dose 1 of glycopyrrolate Topical Wipes; Other Name: DRM04B
Experimental: Dose 2 of glycopyrrolate, 3.0% QD; glycopyrrolate Topical Wipes	Drug: Dose 2 of glycopyrrolate, 3.0% QD; Dose 2 of glycopyrrolate Topical Wipes; Other Name: DRM04B
Active Comparator: Dose 1 of glycopyrronium, 2.5% QD; glycopyrronium Topical Wipes	Drug: Dose 1 of glycopyrronium, 2.5% QD; Dose 1 of glycopyrronium Topical Wipes; Other Name: DRM04
Active Comparator: Dose 2 of glycopyrronium, 3.75% QD; glycopyrronium Topical Wipes	Drug: Dose 2 of glycopyrronium, 3.75% QD; Dose 2 of glycopyrronium Topical Wipes; Other Name: DRM04
Placebo Comparator: Vehicle; Vehicle Topical Wipes	Other: Vehicle; Vehicle Topical Wipes

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4 [ Time Frame: Baseline - Week 4/ET ]

   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 a Minimum 1-grade Improvement in HDSS From Baseline at Week 4 [ Time Frame: Baseline - Week 4 ]
3. Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6 [ Time Frame: Baseline - Week 6 ]
4. Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to 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.
5. Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6 [ Time Frame: Baseline - Week 6 ]

Secondary Outcome Measures :

1. Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4 [ Time Frame: Baseline - Week 4 ]
2. Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6 [ Time Frame: Baseline - Week 6 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or female, 18 years of age or older.
• Primary, axillary hyperhidrosis of at least 6 months duration.
• Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
• For each axilla, a baseline gravimetric measurement of sweat production of at least 50 mg over 5 minutes, while at rest, at room temperature.
• Male or non-pregnant, non-lactating females.

Exclusion Criteria:

• Current pregnancy or lactation.
• Prior surgical procedure for hyperhidrosis.
• Any prior axillary treatment with an anti-hyperhidrosis medical device
• Any prior treatment with an investigational drug within 4 weeks prior to Baseline/Day 1 or within 5 elimination half lives of the active agent, whichever is longer or 6 weeks if the elimination half life is not known. Experimental devices are excluded without the approval of the Medical Monitor.
• Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.
• Subjects with clinically significant abnormalities in laboratory values.
• Subjects with a positive Hepatitis or HIV.Hepatitis B surface antibody positive is allowed only if the subject has a history of having received Hepatitis B vaccination and there are no clinically significant abnormalities in screening liver function tests.
• Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis, within one month prior to Baseline/Day 1.
• Treatment with psychotherapeutic medications for less than 4 months prior to Baseline/Day 1.
• Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks of the baseline visit
• Prior treatment with axillary iontophoresis within 4 weeks of Baseline/Day 1.
• Any previous IV or oral treatment with the study drug.
• Prior treatment with the topical study drug in a previous trial.
• Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
• Presence of a condition, within 10 years of enrollment, that may cause secondary hyperhidrosis
• Menopausal women who have had symptoms of menopause such as sweating or flushing within 3 years of the study may not be enrolled.
• Known 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.
• Abnormal findings on screening ECG deemed clinically significant by the Investigator.
• History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia

Contacts and Locations

Locations

United States, California

California Dermatology & Clinical Research Institute

Encinitas, California, United States, 92024

Center For Dermatology Clinical Research

Fremont, California, United States, 94538

United States, Florida

Olympian Clinical Research

Tampa, Florida, United States, 33609

Kenneth R. Beer MD

West Palm Beach, Florida, United States, 33401

United States, Indiana

Shideler Clinical Research Center

Carmel, Indiana, United States, 46032

United States, Missouri

Saint Louis University Dermatology

Saint Louis, Missouri, United States, 63122

United States, Ohio

Haber Dermatology and Cosmetic Surgery

Beachwood, Ohio, United States, 44122

United States, Tennessee

Rivergate Dermatology Clinical Research Center, PLLC

Goodlettsville, Tennessee, United States, 37072

United States, Texas

DermResearch, Inc

Austin, Texas, United States, 78759

United States, Utah

Dermatology Research Center, Inc.

Salt Lake City, Utah, United States, 84117

United States, Virginia

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States, 23507

United States, Washington

Dermatology Associates

Seattle, Washington, United States, 98101

Women's Clinical Research Center

Seattle, Washington, United States, 98105

Premier Clinical Research

Spokane, Washington, United States, 99204

Canada

Innovaderm Research Inc.

Montreal, Canada, H2K 4L5

Sponsors and Collaborators

Dermira, Inc.

Investigators

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

More Information

• Responsible Party: Dermira, Inc.
• ClinicalTrials.gov Identifier: NCT02129660
• Other Study ID Numbers: DRM04-HH02
• First Posted: May 2, 2014
• Results First Posted: September 4, 2018
• Last Update Posted: September 4, 2018
• Last Verified: August 2018

Additional relevant MeSH terms:

Hyperhidrosis; Sweat Gland Diseases; Skin Diseases; Glycopyrrolate; Adjuvants, Anesthesia; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs