Study of Glycopyrronium in Axillary Hyperhydrosis

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dermira, Inc.; Journey Medical Corporation
• Treatments: Glycopyrrolate

Criteria

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.