Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles

Pollogen

Status: Unknown

Conditions: Facial Wrinkles

Treatments: Device: TriPollar

Study type: Interventional

Funder types: Industry

Identifiers

NCT01858415

PC210118_S, rev. 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Single arm

Experimental group

Treatment:

Device: TriPollar