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Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment

NCT01559233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2012-03-21

No results posted yet for this study

Summary

Patient demand for non-surgical, non-invasive, and no-downtime wrinkle and rhytides treatment procedures has grown dramatically over the past decade as new treatments and technologies have been introduced.

This study was performed in order to evaluate the efficacy and safety of the Invasix FPlus System, an innovative noninvasive system intended for wrinkles and rhytides treatment.

Subjects were treated for face wrinkles and rhytides reduction and followed for 3 months after last treatment. In order to evaluate treatment efficacy, pre and post treatment photos were introduced to three uninvolved physicians for blinded evaluation.

Conditions

  • Facial Wrinkles and Rhytides Reduction

Interventions

DEVICE

FPlus RF device for wrinkles and rhytide reduction

Six RF weekly treatments for face wrinkles and rhytides reduction using the FPlus device.

Sponsors & Collaborators

  • Invasix

    lead INDUSTRY

Principal Investigators

  • Robert Stephen Mulholland, Dr. · Invasix

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • Canada

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 NCT01559233 on ClinicalTrials.gov