Evaluation of Safety and Efficacy of the Apollo™ System for Treatment of Wrinkles and Rhytides
|ClinicalTrials.gov Identifier: NCT01283711|
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : May 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Facelift||Device: apollo device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Safety and Efficacy of the Apollo™ System for Treatment of Wrinkles and Rhytides|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Device: apollo device
RF treatments for wrinkles and rhytides reduction
- To evaluate the safety of the apollo™ system for wrinkles and rhytides treatment. [ Time Frame: 5 months ]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 ]Efficacy of using the apollo™ system for wrinkles and rhytides treatment will be established by level of wrinkle reduction.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|