Qbrexza Cloths for Hyperhidrosis of Amputation Sites

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Glycopyrrolate

Criteria

Inclusion Criteria:

1. History of limb amputation with limb-amputation surgery at least 6 months ago

2. Have a prosthetic device

4. 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:

1. Open sores or wounds on residual limb (at screening and baseline)

2. Known sensitivity to glycopyrronium tosylate or other component of Qbrexza

3. Pregnant or lactating.

4. Use of botulinum toxin within 1 year of the baseline visit

5. Use of topical aluminum chloride within 1 month of the baseline visit

6. 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