Study of Glycopyrronium in Axillary Hyperhydrosis

Journey Medical

Status and phase

Completed

Phase 3

Conditions

Hyperhidrosis

Treatments

Other: Vehicle

Drug: glycopyrronium Topical Wipes

Study type

Interventional

Funder types

Industry

Identifiers

NCT02530281

DRM04-HH04

2015-002052-27 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

344 patients

Sex

All

Ages

9+ years old

Volunteers

No Healthy Volunteers

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

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.