Study of Glycopyrronium in Axillary Hyperhydrosis (NCT02530281) | Clinical Trial Compass
CompletedPhase 3
Study of Glycopyrronium in Axillary Hyperhydrosis
United States344 participantsStarted 2015-07
Plain-language 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.
Who can participate
Age range9 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4
Timeframe: From Baseline to Week 4
2
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Timeframe: From Baseline to Week 4
3
Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Timeframe: From Baseline to Week 4
4
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data