NCT04477187

Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve skin tightening and contour change in lax submental (beneath the chin) tissue.

Detailed description

This is a single-center, unblinded, non-randomized, non-controlled study designed to follow a total of up to 15 qualified and consenting subjects to receive one bipolar fractional radiofrequency microneedling treatment under an IRB approved protocol. Up to 15 subjects will be enrolled and treated at UT Southwestern in the Department of Plastic Surgery. Subjects will be identified from the clinical practice of Dr. Jeffrey Kenkel, Department of Plastic Surgery.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
DEVICE	Dermal Handpiece	Radiofrequency (RF) will travel through the RF generator through the electrodes and into the dermal layer beneath the surface of the skin. The microneedles of the dermal cartridges coupled with the thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-06-13
• Completion: 2022-12-22
• First posted: 2020-07-20
• Last updated: 2023-12-19
• Results posted: 2023-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study