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TriActive+ Radiofrequency (RF) for Non-Invasive Treatment of Wrinkles and Rhytides

NCT01859611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2015-04-07

Study results available
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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.

Conditions

  • Wrinkles
  • Rhytides

Interventions

DEVICE

TriActive+ RF

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.

Sponsors & Collaborators

  • El. En. SpA

    lead INDUSTRY

Principal Investigators

  • Alessandro Bizzari, ElEn · El. En. SpA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-01-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01859611 on ClinicalTrials.gov