Phase 3 N=344 Randomized Quadruple-blind Treatment

Study of Glycopyrronium in Axillary Hyperhydrosis

Hyperhidrosis

Bottom Line

View on ClinicalTrials.gov: NCT02530281 ↗

Enrolled (actual)

344

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 ASDD Item #2 From Baseline at Week 4 — 52.8; 28.3 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: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4	52.8; 28.3	<0.001 sig
PRIMARY Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4	-102.00; -100.34	=0.065
PRIMARY Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4	-80.79; -65.81	=0.065
PRIMARY Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data	-100.56; -88.08	=0.001 sig
SECONDARY Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4	56.5; 23.7	<0.001 sig
SECONDARY Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4	72.4; 53.2	<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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02530281). 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.