Phase 2
Completed N=13
Qbrexza Cloths for Hyperhidrosis of Amputation Sites
Amputation · Hyperhidrosis
Source: ClinicalTrials.gov NCT04924036 ↗
Enrolled (actual)
13
Serious AEs
3.9%
Results posted
Jan 2026
Primary outcomePrimary: ASDD-m Sweat Severity Score — 1.2; 3.6 score on a scale of 0-10
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ASDD-m Sweat Severity Score |
1.2; 3.6 | — |
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
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. Informational only — not medical advice.