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Qbrexza Cloths for Hyperhidrosis of Amputation Sites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04924036
Recruitment Status : Recruiting
First Posted : June 11, 2021
Last Update Posted : February 10, 2022
Sponsor:
Information provided by (Responsible Party):
Stephanie Z Klein, University of Utah

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.

Condition or disease Intervention/treatment Phase
Amputation Hyperhidrosis Drug: glycopyrronium cloths Drug: Placebo Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a Prospective, Double Blinded, Placebo Controlled, Randomized, Cross-over trial.
Masking: Double (Participant, Investigator)
Masking Description: Participants and investigators in the trial will be blinded.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 27, 2021
Estimated Primary Completion Date : September 2, 2023
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Glycopyrronium Cloths then Placebo
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
Qbrexza is an anticholinergic indicated for topical treatment of axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
Other Name: Qbrexza Cloths

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

Placebo then Glycopyrronium Cloths
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
Qbrexza is an anticholinergic indicated for topical treatment of axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
Other Name: Qbrexza Cloths

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




Primary Outcome Measures :
  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 the ASDD-m. [ Time Frame: 4 weeks ]
    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.

  2. Determine if patient's disease-related life quality is changed as a result of glycopyrronium cloth use as measured by the SKINDEX-16 [ Time Frame: 4 weeks ]
    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).


Secondary Outcome Measures :
  1. Determining the change in the average weekly step count of weeks using the study treatment to weeks not using the study treatment. [ Time Frame: 12 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04924036


Contacts
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Contact: Adrianne Evans 8012130375 adrianne.evans@hsc.utah.edu

Locations
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United States, Utah
University of Utah MidValley Dermatology Recruiting
Murray, Utah, United States, 84107
Contact: University of U Dermatology    801-213-0375    adrianne.evans@hsc.utah.edu   
Principal Investigator: Stephanie Z Klein, MD         
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Stephanie Z Klein, MD University of Utah
Publications:

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Responsible Party: Stephanie Z Klein, Assistant Professor, Dermatology, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT04924036    
Other Study ID Numbers: IRB_00139912
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Glycopyrrolate
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs