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

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

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.

Study Overview

• Status: Unknown
• Conditions: Facial Wrinkles
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Ronald L Moy, Inc.
  • Texas
    • Plano, Texas, United States, 75093
      • Reaserch Across America

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm	Device: TriPollar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of TriPollar	Safety will be established by physician's assessment/observation of adverse events.	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.	6 months

Collaborators and Investigators

• Sponsor: Pollogen
• Investigators: Study Director: Mira Barki, PhD, Pollogen

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: April 21, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 11, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: PC210118_S, rev. 01