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

NCT04245696 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-08-06

No results posted yet for this study

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

Conditions

  • Skin Laxity

Interventions

DEVICE

Dermal Handpiece / SubQ Handpiece

Bipolar radiofrequency (RF) travels from the RF generator, through the electrodes and into the dermal layers beneath the surface of the skin. The microneedles of the Dermal and SubQ cartridges coupled with thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.

Sponsors & Collaborators

  • Candela Corporation

    lead INDUSTRY

Principal Investigators

  • Konika Patel Schallen, MD · Candela Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-09
Primary Completion
2021-08-05
Completion
2021-08-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04245696 on ClinicalTrials.gov