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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: Completed NA study, sponsored by Ulthera.
NCT01708551 is a NA study that has completed, run by Ulthera. The registered enrollment target is 59 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Based on histological analyses of biopsied, Ultherapy™-treated, tissue, the changed in the number of sweat glands present at 90days post-treatment will be compared to the number of sweat glands present at baseline.
Interventions
- DEVICE Ulthera System Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-08 |
| Phase | NA |
What the finished NCT01708551 record still lists
NCT01708551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Ulthera System Treatment is the first listed.
NCT01708551 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01708551's enrollment target sits among peer trials
59 1256th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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