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NCT01859611 · ClinicalTrials.gov registry record · NA
TriActive+ Radiofrequency (RF) for Non-Invasive Treatment of Wrinkles and Rhytides
A NA study, sponsored by El. En. SpA.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT01859611: Completed NA study, sponsored by El. En. SpA.
NCT01859611 is a NA study that has completed, run by El. En. SpA. The registered enrollment target is 51 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
NCT01859611, a NA study, has completed, sponsored by El. En. SpA.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study Summary
The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source, the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple treatments. The primary endpoint is observation of changes to the surface by visual and photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort of the treatment and the measurement of adverse events.
Primary Outcome
At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri-orbital wrinkles. Each patient to be evaluated through the 9 grade Fitzpatrick Wrinkling Severity Scale. Wrinkling Score Degree of Elastosis Fine 1-3 Mild Fine to moderate 4-6 Moderate Fine to deep wrinkles 7-
Interventions
- DEVICE TriActive+ RF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-05 |
| Phase | NA |
What the finished NCT01859611 record still lists
NCT01859611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 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 TriActive+ RF is the first listed.
NCT01859611 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01859611 about?
NCT01859611 is a clinical study titled "TriActive+ Radiofrequency (RF) for Non-Invasive Treatment of Wrinkles and Rhytides". The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source, the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple treatments. The primary endpoint is observation of changes to the surface by visual and photographic analysis. Secondary endp...
What is the current status of trial NCT01859611?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2013-05. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01859611?
The interventions under investigation include: TriActive+ RF (DEVICE).
Who is sponsoring clinical trial NCT01859611?
This trial is sponsored by El. En. SpA, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01859611's enrollment target sits among peer trials
51 1279th of 2000 higher than 722 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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