A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

Journey Medical

Status and phase: Completed; Phase 2

Conditions: Hyperhidrosis

Treatments: Drug: glycopyrrolate, 2.0%; Drug: glycopyrrolate, 4.0%; Other: Vehicle; Drug: glycopyrrolate, 1.0%; Drug: glycopyrrolate, 3.0%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02016885

DRM04-HH01

Details and patient eligibility

About

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

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 5 patient groups, including a placebo group

glycopyrrolate, 1.0%

Experimental group

Description:

glycopyrrolate Topical Wipes, 1.0%

Treatment:

Drug: glycopyrrolate, 1.0%

glycopyrrolate, 2.0%

Experimental group

Description:

glycopyrrolate Topical Wipes, 2.0%

Treatment:

Drug: glycopyrrolate, 2.0%

glycopyrrolate, 3.0%

Experimental group

Description:

glycopyrrolate Topical Wipes, 3.0%

Treatment:

Drug: glycopyrrolate, 3.0%

glycopyrrolate, 4.0%

Experimental group

Description:

glycopyrrolate Topical Wipes, 4.0%

Treatment:

Drug: glycopyrrolate, 4.0%

Vehicle

Placebo Comparator group

Description:

Vehicle Topical Wipes

Treatment:

Other: Vehicle