CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
TriActive+ RFdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01859611
NCT01859611N/ACompleted
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Clinical Study to Evaluate the Performance of TriActive+ RF for the Non-Invasive Treatment of Wrinkles and Rhytides

El. En. SpA·interventional·Posted May 22, 2013·Updated Apr 7, 2015

In Brief

A clinical study evaluating TriActive+ RF for Wrinkles and Rhytides. Completed, enrolled 51 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWrinkles, Rhytides
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 22, 2013
Enrollment StartMay 1, 2013
Primary CompletionJan 1, 2014
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.1 years ago

Interventions

TriActive+ RFdevice

Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special "skin contact identification" system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts.