Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the safety of 2 doses of glycopyrrolate compared to 2 doses of glycopyrronium and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied once daily for 4 weeks followed by a 2-week post-dose period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Male or female, 18 years of age or older.

• Primary, axillary hyperhidrosis of at least 6 months duration.

• Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.

• For each axilla, a baseline gravimetric measurement of sweat production of at least 50 mg over 5 minutes, while at rest, at room temperature.

• Male or non-pregnant, non-lactating females.

Exclusion Criteria:

• Current pregnancy or lactation.

• Prior surgical procedure for hyperhidrosis.

• Any prior axillary treatment with an anti-hyperhidrosis medical device

• Any prior treatment with an investigational drug within 4 weeks prior to Baseline/Day 1 or within 5 elimination half lives of the active agent, whichever is longer or 6 weeks if the elimination half life is not known. Experimental devices are excluded without the approval of the Medical Monitor.

• Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.

• Subjects with clinically significant abnormalities in laboratory values.

• Subjects with a positive Hepatitis or HIV.Hepatitis B surface antibody positive is allowed only if the subject has a history of having received Hepatitis B vaccination and there are no clinically significant abnormalities in screening liver function tests.

• Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis, within one month prior to Baseline/Day 1.

• Treatment with psychotherapeutic medications for less than 4 months prior to Baseline/Day 1.

• Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks of the baseline visit

• Prior treatment with axillary iontophoresis within 4 weeks of Baseline/Day 1.

• Any previous IV or oral treatment with the study drug.

• Prior treatment with the topical study drug in a previous trial.

• Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.

• Presence of a condition, within 10 years of enrollment, that may cause secondary hyperhidrosis

• Menopausal women who have had symptoms of menopause such as sweating or flushing within 3 years of the study may not be enrolled.

• Known 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.

• Abnormal findings on screening ECG deemed clinically significant by the Investigator.

• History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia