Overview

This trial is active, not recruiting.

Condition facial wrinkles
Treatment tripollar
Sponsor Pollogen
Start date April 2013
End date December 2013
Trial size 40 participants
Trial identifier NCT01858415, PC210118_S, rev. 01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
tripollar

Primary Outcomes

Measure
Safety of TriPollar
time frame: 6 months
Efficacy of TriPollar
time frame: 6 months

Eligibility Criteria

Male or female participants from 35 years up to 65 years old.

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

Additional Information

Official title Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles and Rhytides
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Pollogen.