Evaluation of Safety and Efficacy of the Apollo™ System for Treatment of Wrinkles and Rhytides
NCT01283711 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2013-05-17
Summary
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.
Conditions
- Facelift
Interventions
- DEVICE
-
apollo device
RF treatments for wrinkles and rhytides reduction
Sponsors & Collaborators
-
Pollogen
lead INDUSTRY
Principal Investigators
-
Mira Barki, Dr. · Pollogen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 35 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-03-31
- Primary Completion
- 2011-09-30
- Completion
- 2011-09-30
Countries
- United States
- Israel
Study Locations
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