Qbrexza Cloths for Hyperhidrosis of Amputation Sites

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.

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

• Determine the change in ASDD-m Impact scores between the end of the treatment and placebo periods.

Inclusion criteria

• 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)

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