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Anticholinergic
Qbrexza Cloths for Excessive Sweating
Phase 2
Waitlist Available
Led By Stephanie Z Klein, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HDSS of 3 or greater (at screening)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing whether Qbrexza Cloths are effective in treating hyperhidrosis of amputation sites.
Who is the study for?
This trial is for individuals with a history of limb amputation at least 6 months ago, who experience excessive sweating at the site and use a prosthetic device. They should have significant sweating that impacts their daily life as measured by specific scores during screening. People can't join if they're pregnant, lactating, sensitive to Qbrexza's ingredients, or have used certain sweat treatments recently.Check my eligibility
What is being tested?
The study tests Qbrexza cloths against placebo in managing excessive sweating at amputation sites. Participants will first be observed for two weeks, then randomly assigned to either the treatment or placebo for four weeks, followed by a two-week break and another four weeks on the alternate treatment.See study design
What are the potential side effects?
Potential side effects from glycopyrronium cloths (Qbrexza) may include skin irritation at the application site, dry mouth, headache, blurred vision, urinary difficulties and constipation. The severity of these side effects varies among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My sweating is severe, affecting my daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Determine if patient's disease-related life quality is changed as a result of glycopyrronium cloth use as measured by the SKINDEX-16
Secondary outcome measures
Determining the change in the average weekly step count of weeks using the study treatment to weeks not using the study treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo then Glycopyrronium ClothsExperimental Treatment2 Interventions
Participants that are randomized to placebo cloths for 4 weeks, then 2 week wash out, then cross over to Glycopyrronium cloths for 4 weeks.
Group II: Glycopyrronium Cloths then PlaceboExperimental Treatment2 Interventions
Participants that are randomized to Glycopyrronium cloths for 4 weeks, then 2 week wash out, then cross over to placebo cloths for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,098 Previous Clinical Trials
1,778,610 Total Patients Enrolled
Stephanie Z Klein, MDPrincipal InvestigatorUniversity of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no open sores or wounds on my residual limb.Your PFFQ score is 4 or higher during screening.I had a limb amputation surgery more than 6 months ago.You are allergic to glycopyrronium tosylate or any other ingredient in Qbrexza.I haven't used aluminum chloride products in the last month.I have not used botulinum toxin in the last year.You have a severity score of 4 or higher on item 2 of the ASDD-m assessment at the screening.You have an artificial body part.My sweating is severe, affecting my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Glycopyrronium Cloths then Placebo
- Group 2: Placebo then Glycopyrronium Cloths
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been enrolled in the current medical experiment?
"Correct. Evident on clinicaltrials.gov, this research initiative, which commenced on September 27th 2021, is currently recruiting participants. 20 individuals are needed to be signed up from a single facility for the study's completion."
Answered by AI
Is recruitment for this experiment currently underway?
"Indeed, the information on clinicaltrials.gov declares that this trial is actively recruiting participants. It was first advertised on September 27th 2021 and its criteria were most recently amended on January 26th 2022; 20 patients are required to be enrolled at one medical centre."
Answered by AI
For what conditions is this therapeutic intervention most effective?
"This particular therapy is suitable for treating secretions, peptic ulcers, in need of quick anticholinergic effects, and excessive sweating."
Answered by AI
Are there any previous studies that have explored the efficacy of this therapy?
"At present, there are thirteen active studies analyzing this intervention with four of them being in Phase 3. Most research is taking place out of Hochiminh and Virginia but the treatment has garnered attention from 1079 sites worldwide."
Answered by AI
To what degree can this treatment be relied upon to provide a secure outcome?
"As this is only a Phase 2 trial, which implies that the treatment has been tested for safety but not efficacy, our team at Power assigned it a score of 2 on their scale."
Answered by AI
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