NCT04606368

Bausch Health Thermage FXL for Use on Lower Face and Submentum Area

Evaluation of the Safety and Efficacy of Sequential Use of Monopolar Radiofrequency Treatment on Lower Face and Submental Area for Fat Reduction and Improvement of Skin Laxity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Lorraine Hickson · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the safety and efficacy of sequential use of monopolar radiofrequency on lower face and submental area, followed by cryolipolysis on the submentum and submandibular area for fat reduction and improvement of skin laxity.

Detailed description

This research study will study subjects who have mild to moderate skin laxity on lower jaw and submentum areas. This will be measured by conducting a treatment using the Thermage FLX system on the lower face and submentum area of the participants. Biopsies will be done on several locations throughout the 12 week trial to assess skin laxity through laboratory measures. Finally, the subject will be asked to complete questionnaires to provide satisfaction and tolerability feedback.

Conditions

• Skin Wrinkling

Interventions

Type	Name	Description
DEVICE	Thermage FLX	Monopolar radiofrequency will be applied through the Thermage FLX machine to the subject's right lower jaw and submentum area.

Timeline

• Start date: 2020-09-29
• Primary completion: 2021-03-17
• Completion: 2021-04-02
• First posted: 2020-10-28
• Last updated: 2021-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study