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NCT01713686 · ClinicalTrials.gov registry record · NA
Evaluation of the Ulthera System for the Treatment of the Decolletage
A NA study of Chest Wrinkles, sponsored by Ulthera.
- Completed
- Registry status
- NA
- Development phase
- 129
- Enrollment target
- 4
- Study locations
NCT01713686: Completed NA study of Chest Wrinkles, sponsored by Ulthera.
NCT01713686 is a NA study of Chest Wrinkles that has completed, run by Ulthera. The registered enrollment target is 129 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01713686, a NA study of Chest Wrinkles, has completed, sponsored by Ulthera.
- COMPLETED
- Registry status
- NA
- Development phase
- 129 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Primary Outcome
Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90
Conditions Studied
Interventions
- DEVICE Ulthera System Treatment
Study Locations (4)
California
- Laser Skin and Surgery Center of Northern California - Sacramento
- Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc. - San Diego
Illinois
- Denova Research - Chicago
Tennessee
- Tennessee Research Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-08 |
| Phase | NA |
What the finished NCT01713686 record still lists
NCT01713686 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Chest Wrinkles appearing as the primary indexed condition, and to 1 intervention - of which Ulthera System Treatment is the first listed.
NCT01713686 reports a single indexed study location in California, Illinois, Tennessee.
Frequently Asked Questions
What is clinical trial NCT01713686 about?
NCT01713686 is a clinical study titled "Evaluation of the Ulthera System for the Treatment of the Decolletage". This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
What is the current status of trial NCT01713686?
This trial is currently completed. It is a NA study. The enrollment target is 129 participants. The study started on 2012-10. Estimated completion is 2013-08.
What conditions does trial NCT01713686 study?
This clinical trial studies the following conditions: Chest Wrinkles.
What interventions are being tested in trial NCT01713686?
The interventions under investigation include: Ulthera System Treatment (DEVICE).
Who is sponsoring clinical trial NCT01713686?
This trial is sponsored by Ulthera, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01713686 being conducted?
This trial has 4 study locations across California, Illinois, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01713686's enrollment target sits among peer trials
129 744th of 2000 higher than 1,257 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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