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NCT01722461 · ClinicalTrials.gov registry record · NA
A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
A NA study, sponsored by Ulthera.
- Terminated
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT01722461 is a NA study that was terminated before completion, run by Ulthera. The registered enrollment target is 120 participants.
The verdict
NCT01722461, a NA study, was terminated before completion, sponsored by Ulthera.
- TERMINATED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will be randomly assigned to receive either active treatments for axillary hyperhidrosis with the Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the energy settings on the device set to deliver no ultrasound energy. Subjects will be randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every one subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days apart. Subjects and study personnel conducting efficacy measures will be blinded to the assigned treatment groups. The study hypothesis is that subjects in the active treatment group will have a greater reduction in underarm sweating compared to those in the sham group as measured by a quality of life questionnaire. All subjects will undergo follow-up assessments at 14 days and 30 days from the date of their first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of their second study treatment. Subjects in the active treatment group will also undergo follow-up assessments at 9 months and 12 months from the date of their second study treatment.
Interventions
- DEVICE Ulthera System
- DEVICE Sham treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2012-11 |
| Est. Completion | 2013-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01722461
The ClinicalTrials.gov registry entry for NCT01722461 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ulthera, which has 42 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ulthera System is the first listed.
NCT01722461 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01722461 about?
NCT01722461 is a clinical study titled "A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis". This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will be randomly assigned to receive either active treatments for axillary hyperhidrosis with the Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the energy settings on ...
What is the current status of trial NCT01722461?
This trial is currently terminated. It is a NA study. The enrollment target is 120 participants. The study started on 2012-11. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01722461?
The interventions under investigation include: Ulthera System (DEVICE), Sham treatment (DEVICE).
Who is sponsoring clinical trial NCT01722461?
This trial is sponsored by Ulthera, which has 42 total clinical trials registered on ClinicalTrials.gov.
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