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

Journey Medical

Status and phase

Completed

Phase 3

Conditions

Hyperhidrosis

Treatments

Drug: Glycopyrronium Topical Wipes

Study type

Interventional

Funder types

Industry

Identifiers

NCT02553798

DRM04-HH06

Details and patient eligibility

About

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.

Full description

Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.

Enrollment

564 patients

Sex

All

Ages

9+ years old

Volunteers

No Healthy Volunteers

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