Overview

Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis

Status:
Completed
Trial end date:
2016-04-01
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.