Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.

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

Details

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

Criteria

Inclusion Criteria:

• Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance

• Male or females

Exclusion Criteria:

• Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated

• Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy

• Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study