Phase 3
N=353
Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
Hyperhidrosis
Bottom Line
View on ClinicalTrials.gov: NCT02530294 ↗Enrolled (actual)
353
Serious AEs
0.3%
Results posted
Aug 2018
Primary outcome: Primary: Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of Axillary Sweating Daily Diary (ASDD) Item #2 From Baseline at Week 4 — 66.1; 26.9 percent of subjects — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- glycopyrronium Topical Wipes (Drug); Vehicle (Other)
- Age
- Pediatric, Adult, Older Adult · 9+ yrs
- Sex
- All
- Sponsor
- Journey Medical Corporation
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of Axillary Sweating Daily Diary (ASDD) Item #2 From Baseline at Week 4 |
66.1; 26.9 | < 0.001 sig |
| PRIMARY Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 |
-115.43; -81.20 | <0.001 sig |
| PRIMARY Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 |
-78.77; -57.94 | < 0.001 sig |
| SECONDARY Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4 |
61.6; 27.8 | < 0.001 sig |
| SECONDARY Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4 |
77.3; 53.3 | < 0.001 sig |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02530294). 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.