Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
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.
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.
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.