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NCT01708551 · ClinicalTrials.gov registry record · NA
Histological Analysis Following Ulthera System Treatment for Hyperhidrosis
A NA study, sponsored by Ulthera.
- Completed
- Registry status
- NA
- Development phase
- 59
- Enrollment target
NCT01708551 is a NA study that has completed, run by Ulthera. The registered enrollment target is 59 participants.
The verdict
NCT01708551, a NA study, has completed, sponsored by Ulthera.
- COMPLETED
- Registry status
- NA
- Development phase
- 59 participants
- Enrollment target
Study Summary
Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in Groups A, B or C will undergo axillary punch biopsies during the course of the trial to determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm treatment depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J). Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40 lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180 days post-treatment #2.
Interventions
- DEVICE Ulthera System Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01708551
The ClinicalTrials.gov registry entry for NCT01708551 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 59 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 1 intervention - of which Ulthera System Treatment is the first listed.
NCT01708551 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01708551 about?
NCT01708551 is a clinical study titled "Histological Analysis Following Ulthera System Treatment for Hyperhidrosis". Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in Groups A, B or C will undergo axillary punch biopsies during the course of the trial to determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm and 3.0mm); either two bilat...
What is the current status of trial NCT01708551?
This trial is currently completed. It is a NA study. The enrollment target is 59 participants. The study started on 2012-08. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01708551?
The interventions under investigation include: Ulthera System Treatment (DEVICE).
Who is sponsoring clinical trial NCT01708551?
This trial is sponsored by Ulthera, which has 42 total clinical trials registered on ClinicalTrials.gov.
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