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NCT03416348 · ClinicalTrials.gov registry record · Phase 1
Hyperhidrosis, Developing a Treatment Approach Aims 1 & 2
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT03416348: Completed Phase 1 study, sponsored by University of Utah.
NCT03416348 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 95 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03416348, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
The objective is to establish an evidence base for a hyperhidrosis treatment algorithm in amputees. This project will address a problem that has troubled Service members, Veterans, and civilians with amputations for decades, impacting satisfaction with prosthetic use, residual limb skin health, and negatively affecting quality of life. Prior research in this area has been limited and insufficient. The Investigators are confident that improving the evaluation and treatment of residual limb hyperhidrosis will reduce the secondary health consequences of amputation and will lead to improved quality of life. This will be accomplish by completing the following specific aims. Aim 1: Test the validity of the Minor iodine-starch test in amputees. Hypothesis: 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 Aim 2: Test the effectiveness of a prescription strength topical antiperspirant (Aluminum Chloride 20%) on hyperhidrosis of the residual limb. Hypothesis: Aluminum Chloride will be more effective at controlling sweating than placebo
Primary Outcome
The outcome measure of Aim 1 will be measuring the Hyperhidrosis Disease Severity Scale (HDSS). The HDSS is scored on a number scale of 1-4. Score range from 1 (lowest) demonstrating sweating (hyperhidrosis) is least noticeable and does not interfere with daily activities (least impactful) to 4 (highest) sweating is intolerable and interferes significantly with daily activities. This measurement will be completed in a single site visit.
Interventions
- DRUG Alcohol
- DRUG Aluminum Chloride 20% (deodorant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2018-05-08 |
| Est. Completion | 2022-02-14 |
| Phase | Phase 1 |
What the finished NCT03416348 record still lists
NCT03416348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 2 interventions - of which Alcohol is the first listed.
NCT03416348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03416348 about?
NCT03416348 is a clinical study titled "Hyperhidrosis, Developing a Treatment Approach Aims 1 & 2". The objective is to establish an evidence base for a hyperhidrosis treatment algorithm in amputees. This project will address a problem that has troubled Service members, Veterans, and civilians with amputations for decades, impacting satisfaction with prosthetic use, residual limb skin health, and ...
What is the current status of trial NCT03416348?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2018-05-08. Estimated completion is 2022-02-14.
What interventions are being tested in trial NCT03416348?
The interventions under investigation include: Alcohol (DRUG), Aluminum Chloride 20% (deodorant) (DRUG).
Who is sponsoring clinical trial NCT03416348?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03416348's enrollment target sits among peer trials
95 610th of 2000 higher than 1,386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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