Facial Wrinkles
Conditions
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.
Interventions
DEVICETriPollar
Sponsors
Pollogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Listed in approved protocol, and ICF
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed