Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment
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|ClinicalTrials.gov Identifier: NCT01559233|
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : March 21, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Facial Wrinkles and Rhytides Reduction||Device: FPlus RF device for wrinkles and rhytide reduction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||March 2012|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559233
|AestheticPlastic Surgery Practice, SpaMedica|
|Toronto, Canada, ON M5R 3N8|
|Principal Investigator:||Robert Stephen Mulholland, Dr.||Invasix|