Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment
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.
|Facial Wrinkles and Rhytides Reduction||Device: FPlus RF device for wrinkles and rhytide reduction|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment|
- Lack of adverse events during treatments with the FPlus device and 3 months following last treatment. [ Time Frame: 4.5 months ]
- Facial wrinkle reduction rate following 6 treatments with the FPlus device, as agreed 3 blinded dermatologists, based on Fitzpatrick wrinkle and elastosis scale. [ Time Frame: 4.5 months ]
|Study Start Date:||February 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Device: FPlus RF device for wrinkles and rhytide reduction
Six RF weekly treatments for face wrinkles and rhytides reduction using the FPlus device.
Other Name: RF treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559233
|AestheticPlastic Surgery Practice, SpaMedica|
|Toronto, Canada, ON M5R 3N8|
|Principal Investigator:||Robert Stephen Mulholland, Dr.||Invasix|