Qbrexza Cloths for Hyperhidrosis of Amputation Sites

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Arm #1: At Baseline participants will receive active treatment for 4 weeks, completing a 1 week wash out period and then concluding with 4 weeks of placebo treatment Arm #2: At baseline participants will receive placebo for 4 weeks, completing a 1 week washout period and then concluding with active treatment for 4 weeks.

Official Title
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A Prospective Trial to Assess How Glycopyrronium Cloths at the Amputation Site of Limb Amputees Changes the Severity of Hyperhidrosis and the Fit and Function of the Prosthetic Measured by Patient Reported Outcomes

Conditions
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Amputation, Hyperhidrosis

Intervention / Treatment
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* Drug: glycopyrronium cloths
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of limb amputation with limb-amputation surgery at least 6 months ago 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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a Prospective, Double Blinded, Placebo Controlled, Randomized, Cross-over trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Glycopyrronium Cloths then Placebo<br>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<br>* Qbrexza is an anticholinergic indicated for topical treatment of axillary hyperhidrosis in adults and pediatric patients 9 years of age and older<br>* Other names: Qbrexza Cloths;Drug: Placebo<br>* Placebo for this study are cloths that look like the qbrexza cloths but do not have any active ingredient.<br>|
| Other: Placebo then Glycopyrronium Cloths<br>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<br>* Qbrexza is an anticholinergic indicated for topical treatment of axillary hyperhidrosis in adults and pediatric patients 9 years of age and older<br>* Other names: Qbrexza Cloths;Drug: Placebo<br>* Placebo for this study are cloths that look like the qbrexza cloths but do not have any active ingredient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 the ASDD-m. | ASDD-m is a questionnaire for axillary hyperhidrosis measuring for presence, severity, impact and bothersomeness of the patient's sweating. There is a question that a patient rates from 0-10 (0 meaning no sweating at all, and 10 meaning worst possible sweating). Then there are two questions grated on a scale of 0-4 (0 meaning not at all and 4 meaning an extreme amount). So in total of 18 points with 0 meaning not bothered by swat at all, and 18 meaning that patients are extremely bothered by sweat. | 4 weeks | 
| Determine if patient's disease-related life quality is changed as a result of glycopyrronium cloth use as measured by the SKINDEX-16 | Skindex-16 has 16 questions that accurately and sensitively measures how much patients are bothered by their skin conditions. We will determine the change in SKINDEX-16 scores between treatment and placebo periods. Skindex includes 16 questions that are rated on a scale from 0-6 (0 meaning never bothered by skin condition and 6 meaning always bothered by skin condition). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining the change in the average weekly step count of weeks using the study treatment to weeks not using the study treatment. | Patients will wear an activity monitor and we will compare their weekly average step count during the screening period to week 4 to the treatment period. | 12 weeks |