Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: Dose 1 of glycopyrrolate, 2.0% QD; Dose 2 of glycopyrrolate, 3.0% QD; Dose 1 of glycopyrronium, 2.5% QD; Dose 2 of glycopyrronium, 3.75% QD; Vehicle
Intervention description: Dose 1 of glycopyrrolate Topical Wipes; Dose 2 of glycopyrrolate Topical Wipes; Dose 1 of glycopyrronium Topical Wipes; Dose 2 of glycopyrronium Topical Wipes; Vehicle Topical Wipes
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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