Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles
- Conditions
- Facial Wrinkles
- Interventions
- Device: TriPollar
- Registration Number
- NCT01858415
- Lead Sponsor
- Pollogen
- Brief Summary
The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the TriPollar.
- Detailed Description
The TriPollar 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Subject read, discussed and signed the Consent Form,
- Healthy female/male aged 35 65 years,
- Has facial wrinkles,
- Capable of reading, understanding and following instructions of the procedure to be applied,
- Able and willing to comply with the treatment and follow-up schedule.
- Listed in approved protocol, and ICF
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm TriPollar -
- Primary Outcome Measures
Name Time Method Safety of TriPollar 6 months Safety will be established by physician's assessment/observation of adverse events.
Efficacy of TriPollar 6 months Efficacy will be established by level of wrinkle reduction at 3 m fu based on photos evaluation by independent physicians.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Reaserch Across America
🇺🇸Plano, Texas, United States
Ronald L Moy, Inc.
🇺🇸Beverly Hills, California, United States