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Neurotoxin

Botulinum Toxin Type A (Botox) for Excessive Sweating

Phase 1
Waitlist Available
Led By Colby Hansen, 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
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 20 weeks
Awards & highlights

Study Summary

This trial will test the validity of the Minor iodine-starch test in amputees and also treat the residual limb hyperhidrosis with Botox. The hypothesis is that the iodine-starch test is a valid diagnostic tool of hyperhidrosis and can be useful for the identification of focal areas of sweating on a residual limb and that treatment of residual limb hyperhidrosis with Botox will result in improved patient reports of excessive sweating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to comply with all study procedures and be available for the duration of the study.
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Any person who is 18 years of age or older is either male or female.
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and physical examination The person is generally in good health, as evidenced by their medical history and physical examination.
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At least 6 months must have passed since your last injection with any botulinum toxin products.
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After a person has surgery to amputate a limb, they should wait at least 6 months before starting any intense physical activity.
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if you can’t use a real arm If you can't use a real arm, you can have a prosthetic device.
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The patient has a score of 2 or greater on the HDSS scale and has failed prior treatment with topical aluminum chloride.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The effectiveness of botulinum toxin therapy in subjects who fail Aluminum Chloride as assessed by the Hyperhidrosis Disease Severity Scale (HDSS)
Secondary outcome measures
The effectiveness of botulinum toxin therapy in subjects who fail Aluminum Chloride as assessed by the Sweating Intensity Visual Scale (SIVS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Botulinum Toxin TherapyExperimental Treatment1 Intervention
Test the effectiveness of Botulinum Toxin therapy in subjects who fail or do not tolerate Aluminum Chloride. We plan to conduct an open label study of Botox, up to 400 units, in amputees who have failed treatment with a topical antiperspirant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iodine
FDA approved

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,094 Previous Clinical Trials
1,775,492 Total Patients Enrolled
U.S. Army Medical Research and Development CommandFED
285 Previous Clinical Trials
245,134 Total Patients Enrolled
US Department of Veterans AffairsFED
867 Previous Clinical Trials
487,825 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
Missouri
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~4 spots leftby Apr 2025