Evaluation of Safety and Efficacy of the Apollo™ System for Treatment of Wrinkles and Rhytides
Non-invasive, energy-based, aesthetic treatments are becoming increasingly popular among female and male patients of all ages. Different technologies are presently available to rejuvenate skin, including therapeutic ultrasound, lasers and intense pulsed light (IPL), however radiofrequency has emerged as the most effective and versatile modality for the broadest range of body and facial treatments, including non-invasive wrinkle treatment.
The apollo™ system is an RF system, based on the TriPollar™ technology. The technology is based on three or more electrodes designed to deliver RF current focused into the skin, thus generating heat in the dermal layer. Selective and focused electro-heating of the skin is intended to stimulate collagen remodeling in the dermal layer resulting in non invasive wrinkle treatment.
The apollo™ system is intended for use in dermatologic and general surgical procedures for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the Apollo™ System for facial wrinkles and rhytides treatments.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Safety and Efficacy of the Apollo™ System for Treatment of Wrinkles and Rhytides|
- To evaluate the safety of the apollo™ system for wrinkles and rhytides treatment. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]The safety of using the apollo™ system for wrinkles and rhytides treatment will be established by physician's assessment/observation of adverse events.
- • To evaluate the efficacy of the apollo™ system for wrinkles and rhytides treatment. [ Time Frame: 5 months ] [ Designated as safety issue: No ]Efficacy of using the apollo™ system for wrinkles and rhytides treatment will be established by level of wrinkle reduction.
|Study Start Date:||March 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Device: apollo device
RF treatments for wrinkles and rhytides reduction
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283711
|United States, Florida|
|Steven D. Shapiro MD|
|Palm Beach Gardens, Florida, United States, 33410|
|Kaplan Medical center|
|Rehovot, Israel, 76610|
|Study Director:||Mira Barki, Dr.||Pollogen|