Qbrexza Cloths for Hyperhidrosis of Amputation Sites

Completed · Phase 2 · Has a placebo group

Conditions studied: Amputation, Hyperhidrosis

In brief

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.

Key facts

Study ID

NCT04924036

Run by

University of Utah

People needed

13

Starts

2021-09-27

Expected to finish

2023-12-03

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Utah MidValley Dermatology — Murray, Utah, United States

Full record on ClinicalTrials.gov

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