Clinical trial NCT02016885: A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Official title: A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperhidrosis
Lead sponsor: Journey Medical Corporation
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.

Detailed description: This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. There are 5 arms in this study.

Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.

Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK samples will be taken from 20 to 30 subjects participating in the study.

Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years of age or older.
* Primary, axillary hyperhidrosis of at least 6 months duration.
* A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
* A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
* Male or non-pregnant, non-lactating females.

Exclusion Criteria:

* Prior surgical procedure for hyperhidrosis.
* Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
* Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
* Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
* Prior axillary treatment with axillary iontophoresis within 4 weeks.
* Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
* Known history of a condition that may cause secondary hyperhidrosis.
* Known history of Sjögren's syndrome or Sicca syndrome.
* Abnormal findings on screening ECG deemed clinically significant by the Investigator.

Primary outcomes:
measure: Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
timeFrame: Baseline - Week 4
measure: Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4
timeFrame: Baseline - Week 4
Secondary outcomes:
measure: Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
timeFrame: Baseline - Week 4
measure: Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
timeFrame: Baseline - Week 6
measure: Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
timeFrame: Baseline - Week 6
measure: Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4
timeFrame: Baseline - Week 4
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Little Rock
country: United States
facility: Gary M. Petrus, MD, PA
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research
state: California
city: Miami
country: United States
facility: Florida Academic Dermatology Center
state: Florida
city: West Palm Beach
country: United States
facility: Kenneth R. Beer, MD, PA
state: Florida
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Wichita
country: United States
facility: Cypress Medical Research Center, LLC
state: Kansas
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University Dermatology
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Verona
country: United States
facility: The Dermatology Group, PC
state: New Jersey
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Richmond
country: United States
facility: Westend Dermatology Associates
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Seattle
country: United States
facility: Women's Clinical Research Center
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Dermira, Inc.
name: Lynne M Deans, MT
role: STUDY_DIRECTOR
References:
citation: Pariser DM, Lain EL, Mamelok RD, Drew J, Mould DR. Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis. Clin Pharmacokinet. 2021 May;60(5):665-676. doi: 10.1007/s40262-020-00975-y. Epub 2021 Jan 12.