Phase 2
N=198
A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Hyperhidrosis
Bottom Line
View on ClinicalTrials.gov: NCT02016885 ↗Enrolled (actual)
198
Serious AEs
0.5%
Results posted
Sep 2018
Primary outcome: Primary: Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4 — 14; 20; 21; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- glycopyrrolate, 1.0% (Drug); glycopyrrolate, 2.0% (Drug); glycopyrrolate, 3.0% (Drug); glycopyrrolate, 4.0% (Drug); Vehicle (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Journey Medical Corporation
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4 |
14; 20; 21; 18; 9 | — |
| PRIMARY Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4 |
-56.63; -67.17; -91.39; -88.40; -55.80 | — |
| SECONDARY Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4 |
27; 30; 35; 25; 28 | — |
| SECONDARY Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6 |
-32.08; -51.36; -72.23; -57.15; -55.14 | — |
| SECONDARY Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6 |
24; 27; 29; 23; 25 | — |
| SECONDARY Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4 |
-6.2; -6.6; -7.0; -5.9; -3.8 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 years of age or older.
- Primary, axillary hyperhidrosis of at least 6 months duration.
- A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
- A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
- Male or non-pregnant, non-lactating females.
Exclusion Criteria
- Prior surgical procedure for hyperhidrosis.
- Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
- Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
- Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
- Prior axillary treatment with axillary iontophoresis within 4 weeks.
- Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
- Known history of a condition that may cause secondary hyperhidrosis.
- Known history of Sjögren's syndrome or Sicca syndrome.
- Abnormal findings on screening ECG deemed clinically significant by the Investigator.
Data sourced from ClinicalTrials.gov (NCT02016885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.