Phase 2 N=13 Randomized Double-blind Treatment

Qbrexza Cloths for Hyperhidrosis of Amputation Sites

Amputation · Hyperhidrosis

Bottom Line

View on ClinicalTrials.gov: NCT04924036 ↗

Enrolled (actual)

Serious AEs

3.9%

Results posted

Jan 2026

Primary outcome: Primary: ASDD-m Sweat Severity Score — 1.2; 3.6 score on a scale of 0-10

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: glycopyrronium cloths (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Utah
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY ASDD-m Sweat Severity Score	1.2; 3.6	—

Summary

This is a Prospective, Double Blinded, Placebo Controlled, Randomized, Cross-over trial using Qbrexza Cloths to treat hyperhidrosis of amputation sites. There is a 2 week screening period where patients will use an activity monitor to establish baseline activity level, then patients will be randomized to receive either Qbrexza cloths or placebo for 4 weeks, then a 2 week washout, and then a 4-week cross-over treatment period.

Eligibility Criteria

Inclusion Criteria

History of limb amputation with limb-amputation surgery at least 6 months ago
Have a prosthetic device
HDSS of 3 or greater (at screening) 5. ASDD-m Item 2 severity score >= 4 (at screening) 6. PFFQ score >= 4 (at screening)

Exclusion Criteria

Open sores or wounds on residual limb (at screening and baseline)
Known sensitivity to glycopyrronium tosylate or other component of Qbrexza
Pregnant or lactating.
Use of botulinum toxin within 1 year of the baseline visit
Use of topical aluminum chloride within 1 month of the baseline visit
Any significant concurrent condition that could adversely affect the patient's participation and/or the assessment of the safety and efficacy in the study in the opinion of the investigator

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04924036). 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.