NCT01559233

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Invasix · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	FPlus RF device for wrinkles and rhytide reduction	Six RF weekly treatments for face wrinkles and rhytides reduction using the FPlus device.

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2012-03-21
• Last updated: 2012-03-21

Locations

1 site across 1 country: Canada