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

Facial Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01858415
• Other study ID #: PC210118_S, rev. 01
• Status: Unknown status
• Phase: N/A
• First received: April 21, 2013
• Last updated: August 11, 2013
• Start date: April 2013

Study information

• Verified date: August 2013
• Source: Pollogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Wrinkles

Intervention

Device:
• TriPollar

Locations

Country	Name	City	State
United States	Ronald L Moy, Inc.	Beverly Hills	California
United States	Reaserch Across America	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pollogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of TriPollar	Safety will be established by physician's assessment/observation of adverse events.	6 months
Primary	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