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Bipolar RF Microneedling for Improved Laxity and Lift of the Submental and Neck Tissue and Effect on Elastin

Skin Laxity Clinical Trial

Official title:
Clinical Assessment of Bipolar Radiofrequency Microneedling for Improved Laxity and Lift of the Submental and Neck Tissue

Clinical Trial Summary

This study is being conducted to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve lift in lax submental (beneath the chin) and neck tissue

Clinical Trial Description

A multi-center, blinded, non-randomized, non-controlled study Up to 60 eligible participants will be enrolled at up to three (3) sites. Participants will receive one (1) treatment in the submental/neck area. Participants will complete follow-up visits for clinical evaluation at Day 14, 1 Month, 3 Month, and 6 Months after the study treatment. Standard photography will be obtained at Screening to the 6 Month follow-up, and 3D photography will be obtained at Screening, Month 3, and Month 6 visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04245696
Study type Interventional
Source Candela Corporation
Contact
Status Withdrawn
Phase N/A
Start date March 9, 2020
Completion date August 5, 2021
View Details
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