Hyperhidrosis | Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis
Hyperhidrosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Dose 1 of glycopyrrolate, 2.0% QDDose 1 of glycopyrrolate Topical Wipes
Drug:Dose 2 of glycopyrrolate, 3.0% QDDose 2 of glycopyrrolate Topical Wipes
Drug:Dose 1 of glycopyrronium, 2.5% QDDose 1 of glycopyrronium Topical Wipes
Drug:Dose 2 of glycopyrronium, 3.75% QDDose 2 of glycopyrronium Topical Wipes
Other:VehicleVehicle Topical Wipes
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Dose 1 of glycopyrrolate, 2.0% QDglycopyrrolate Topical Wipes
Dose 2 of glycopyrrolate, 3.0% QDglycopyrrolate Topical Wipes
Dose 1 of glycopyrronium, 2.5% QDglycopyrronium Topical Wipes
Dose 2 of glycopyrronium, 3.75% QDglycopyrronium Topical Wipes
VehicleVehicle Topical Wipes
Start Date: April 2014
Completed Date: January 2015
Phase: Phase 2
Primary Outcome: Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
Secondary Outcome: Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Study sponsors, principal investigator, and references
Principal Investigator: Lynne M. Deans, MT
Lead Sponsor: Dermira, Inc.