A Phase 2 interventional study of glycopyrronium cloths and Placebo in Amputation and Hyperhidrosis, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by University of Utah · Phase 2, Interventional, and Treatment
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.
BACKGROUND:
Approximately 1 in 190 people in the United States have experienced a limb amputation. Of these patients with amputations, over sixty percent suffer from hyperhidrosis at the amputation site. Amputation site hyperhidrosis interferes with these patients' daily activities as well as their ability to engage in vigorous activity beneficial to their overall health. In fact, amputees identified heat and sweating as what reduces their quality of life more than any other problem, even pain. Despite the significant impact hyperhidrosis has on amputees' quality of life and ability to stay physically active, there are no self-administered, non-invasive, well-tolerated treatments for amputation site hyperhidrosis. Botulinum toxin injections are an available treatment option for focal hyperhidrosis. However, the large surface area covered by the prosthetic and prosthetic sleeve often necessitates very large volumes of botulinum toxin for effective treatment at amputation sites. This is costly, making it difficult to be able to treat the entire affected area. Botulinum toxin also requires office visits and repeat treatments every 4-6 months.
Glycopyrronium cloths are a unique treatment possibility, because they can easily be used over a large body surface area and can easily be self-administered at home. At this time, glycopyrronium cloths are only FDA approved for use in the axillae. There are two primary differences between the use of these cloths at amputation sites and axillae: 1) the amputation site is occluded during daytime hours by the prosthetic and 2) the area treated for amputation-site hyperhidrosis (the entire area covered by the prosthetic sleeve) is typically a much larger surface area than the axillae. These factors could significantly increase systemic absorption of glycopyrronium and cause systemic side effects. In order to minimize these effects, the medication will be applied at night, when the site is not occluded. Frequent visits with the investigator will also encourage early reporting of symptoms which could be the result of systemic side effects associated with use on a larger surface area. Patient reported outcomes will be used to determine effectiveness.
This is a Prospective, Double Blinded, Placebo Controlled, Randomized, Cross-over trial.
Participants will be randomized, using a 1:1 ratio, to one of 2 arms:
Primary Objective 1. Determine if daily use of glycopyrronium cloths applied to the amputation site decreases hyperhidrosis severity and improved fit and function of the prosthetic as measured by patient reported outcome measures.
Primary Endpoints
1. Determine the change in ASDD-m Impact scores between the end of the treatment and placebo periods.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 13 is below the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
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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:
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
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
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
Placebo for this study are cloths that look like the qbrexza cloths but do not have any active ingredient.
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.
Time frame: 4 weeks
| Milestone | Glycopyrronium Cloths, Then Placebo | Placebo, Then Glycopyrronium Cloths |
|---|---|---|
| Started | 7 | 6 |
| Completed | 3 | 4 |
| Not completed | 4 | 2 |
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.
| score on a scale of 0-10 | Glycopyrronium Cloths | Placebo |
|---|---|---|
| ASDD-m Sweat Severity Score | 1.2 ± 2.0 | 3.6 ± 2.9 |
Collected over 17 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glycopyrronium Cloths | 0/13 (0%) | 1/13 (7.7%) | 5/13 (38.5%) |
| Placebo | 0/13 (0%) | 0/13 (0%) | 3/13 (23.1%) |
| Event | Glycopyrronium Cloths | Placebo |
|---|---|---|
| Urinary RetentionRenal and urinary disorders | 1/13 | 0/13 |
| Event | Glycopyrronium Cloths | Placebo |
|---|---|---|
| Dry MouthGeneral disorders | 2/13 | 0/13 |
| FolliculitisSkin and subcutaneous tissue disorders | 2/13 | 2/13 |
| AnhidrosisSkin and subcutaneous tissue disorders | 1/13 | 0/13 |
| Exacerbated asthmaRespiratory, thoracic and mediastinal disorders | 1/13 | 0/13 |
| Irritant contact dermatitisSkin and subcutaneous tissue disorders | 1/13 | 1/13 |
| cystSkin and subcutaneous tissue disorders | 1/13 | 0/13 |
| vertigoNervous system disorders | 0/13 | 1/13 |
| generalized fatigueGeneral disorders | 0/13 | 1/13 |
| Lupus FlareSkin and subcutaneous tissue disorders | 0/13 | 1/13 |
| Age, Categorical(Participants) | Glycopyrronium Cloths Then Placebo | Placebo Then Glycopyrronium Cloths | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 6 | 13 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Glycopyrronium Cloths Then Placebo | Placebo Then Glycopyrronium Cloths | Total |
|---|---|---|---|
| Mean | 43.3 ± 14.9 | 43.6 ± 14.1 | 43.5 ± 14.5 |
| Sex: Female, Male(Participants) | Glycopyrronium Cloths Then Placebo | Placebo Then Glycopyrronium Cloths | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 6 | 5 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Glycopyrronium Cloths Then Placebo | Placebo Then Glycopyrronium Cloths | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 7 | 4 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Glycopyrronium Cloths Then Placebo | Placebo Then Glycopyrronium Cloths | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 7 | 6 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Glycopyrronium Cloths Then Placebo | Placebo Then Glycopyrronium Cloths | Total |
|---|---|---|---|
| United States | 7 | 6 | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2021 to primary completion in Dec 2023, 26 months.
Results were first posted in Jan 2026, 2 years 1 month after primary completion.
Of 14 phase 2 interventional studies under Hyperhidrosis, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 11. This study's 26 months is above that.
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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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