Clinical trial NCT02129660: Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperhidrosis
Lead sponsor: Journey Medical Corporation
Sponsor class: INDUSTRY
First posted: 2014-05-02
Enrollment: 105
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 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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
timeFrame: Baseline - Week 4/ET
measure: Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
timeFrame: Baseline - Week 4
measure: Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
timeFrame: Baseline - Week 6
measure: Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4
timeFrame: Baseline - Week 4
measure: Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
timeFrame: Baseline - Week 6
Secondary outcomes:
measure: Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
timeFrame: Baseline - Week 4
measure: Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6
timeFrame: Baseline - Week 6
Other outcomes:
Locations:
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: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Kenneth R. Beer MD
state: Florida
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Saint Louis
country: United States
facility: Saint Louis University Dermatology
state: Missouri
city: Beachwood
country: United States
facility: Haber Dermatology and Cosmetic Surgery
state: Ohio
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Clinical Research Center, PLLC
state: Tennessee
city: Austin
country: United States
facility: DermResearch, 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: 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
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
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.