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

Pollogen40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Facial Wrinkles

Interventions

TriPollarDEVICE

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Ronald L Moy, Inc.

Beverly Hills, California, United States

Reaserch Across America

Plano, Texas, United States

Outcomes

Primary Outcomes

Safety of TriPollar

Safety will be established by physician's assessment/observation of adverse events.

Time frame: 6 months

Efficacy of TriPollar

Efficacy will be established by level of wrinkle reduction at 3 m fu based on photos evaluation by independent physicians.

Time frame: 6 months

Data from ClinicalTrials.gov

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