Qbrexza Cloths for Hyperhidrosis of Amputation Sites

NCT04924036 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB_00139912
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation; Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• ASDD-m Sweat Severity Score

  ASDD-m is a questionnaire for axillary hyperhidrosis measuring for presence, severity, impact and bothersomeness of the patient's sweating. Question #1 is "Rate the Sweating at its worst" that a patient rates from 0-10 (0 meaning no sweating at all, and 10 meaning worst possible sweating). This single score was used from the number of responses listed below while patient was on active drug, and while they were on placebo. Patients completed this questionnaire daily throughout the study (4 weeks of glycopyrronium cloths, 1 week of washout, and 4 weeks of placebo). Therefore, each patient could have up to 28 entries, however, some patients ended the study early, and some missed a few surveys.

  4 weeks

Study Arms (2)

Glycopyrronium Cloths then Placebo

OTHER

Participants that are randomized to Glycopyrronium cloths for 4 weeks, then 2 week wash out, then cross over to placebo cloths for 4 weeks.

Drug: glycopyrronium cloths; Drug: Placebo

Placebo then Glycopyrronium Cloths

OTHER

Participants that are randomized to placebo cloths for 4 weeks, then 2 week wash out, then cross over to Glycopyrronium cloths for 4 weeks.

Drug: glycopyrronium cloths; Drug: Placebo

Interventions

glycopyrronium cloths DRUG

Qbrexza is an anticholinergic indicated for topical treatment of axillary hyperhidrosis in adults and pediatric patients 9 years of age and older

Also known as: Qbrexza Cloths

Glycopyrronium Cloths then Placebo; Placebo then Glycopyrronium Cloths

Placebo DRUG

Placebo for this study are cloths that look like the qbrexza cloths but do not have any active ingredient.

Glycopyrronium Cloths then Placebo; Placebo then Glycopyrronium Cloths

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah MidValley Dermatology

Murray, Utah, 84107, United States

Location

Related Publications (8)

• Chren MM. The Skindex instruments to measure the effects of skin disease on quality of life. Dermatol Clin. 2012 Apr;30(2):231-6, xiii. doi: 10.1016/j.det.2011.11.003. Epub 2011 Dec 20.

  PMID: 22284137 BACKGROUND

• Hagberg K, Branemark R. Consequences of non-vascular trans-femoral amputation: a survey of quality of life, prosthetic use and problems. Prosthet Orthot Int. 2001 Dec;25(3):186-94. doi: 10.1080/03093640108726601.

  PMID: 11860092 BACKGROUND

• Hansen C, Godfrey B, Wixom J, McFadden M. Incidence, severity, and impact of hyperhidrosis in people with lower-limb amputation. J Rehabil Res Dev. 2015;52(1):31-40. doi: 10.1682/JRRD.2014.04.0108.

  PMID: 26230919 BACKGROUND

• Strutton DR, Kowalski JW, Glaser DA, Stang PE. US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey. J Am Acad Dermatol. 2004 Aug;51(2):241-8. doi: 10.1016/j.jaad.2003.12.040.

  PMID: 15280843 BACKGROUND

• Nelson LM, DiBenedetti D, Pariser DM, Glaser DA, Hebert AA, Hofland H, Drew J, Ingolia D, Gillard KK, Fehnel S. Development and validation of the Axillary Sweating Daily Diary: a patient-reported outcome measure to assess axillary sweating severity. J Patient Rep Outcomes. 2019 Sep 5;3(1):59. doi: 10.1186/s41687-019-0148-8.

  PMID: 31486951 BACKGROUND

• Lamb YN. Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis: A Profile of Its Use. Clin Drug Investig. 2019 Nov;39(11):1141-1147. doi: 10.1007/s40261-019-00853-x.

  PMID: 31571127 BACKGROUND

• Solish N, Bertucci V, Dansereau A, Hong HC, Lynde C, Lupin M, Smith KC, Storwick G; Canadian Hyperhidrosis Advisory Committee. A comprehensive approach to the recognition, diagnosis, and severity-based treatment of focal hyperhidrosis: recommendations of the Canadian Hyperhidrosis Advisory Committee. Dermatol Surg. 2007 Aug;33(8):908-23. doi: 10.1111/j.1524-4725.2007.33192.x.

  PMID: 17661933 BACKGROUND

• Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.

  PMID: 18295618 BACKGROUND

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Stephanie Zone, MD
• Organization: University of Utah Dermatology

dermatology@utah.edu

801-581-6465

Study Officials

• Stephanie Z Klein, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators in the trial will be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Dermatology, Principal Investigator

Model Details: This is a Prospective, Double Blinded, Placebo Controlled, Randomized, Cross-over trial.

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: September 27, 2021
• Primary Completion: December 2, 2023
• Study Completion: December 3, 2023
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)