NCT01566396

Evaluation of Safety and Efficacy of the 3F Applicator (A3F) for Treatment of Facial Wrinkles

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Pollogen · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. This study was designed in order to evaluate the safety and efficacy of the A3F for treatment of facial wrinkles.

Detailed description

The need for cosmetic facial enhancement procedures with minimal down time and low risk has led to the development of methods for non-surgical skin rejuvenation. Various ablative lasers were developed, which remove the full skin surface in a controlled manner1,2. However, the prolonged recovery and the significant risks prompted the development of fractional lasers which ablate the skin in a fractional manner, leaving untreated areas to improve healing process3. In the past few years, fractional RF systems have been introduced that enable controlled skin resurfacing accompanied with dermal collagen remodeling4,5,6. The new 3F Applicator (A3F, trade name TriFractional) from Pollogen™ is designed to enable skin resurfacing and treatment of wrinkles using radiofrequency energy. The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. This study was designed in order to evaluate the safety and efficacy of the A3F for treatment of facial wrinkles.

Conditions

• Facial Wrinkles

Interventions

Type	Name	Description
DEVICE	A3F	A3F fractional RF treatments for facial wrinkles

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-03-29
• Last updated: 2012-10-19

Locations

2 sites across 1 country: United States