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

NCT04606368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-09-29

No results posted yet for this study

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.

Conditions

  • Skin Wrinkling

Interventions

DEVICE

Thermage FLX

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

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • Solta Medical

    collaborator INDUSTRY

  • Lorraine Hickson

    lead OTHER

Principal Investigators

  • Leyda R Bowes, MD · Riverchase Dermatology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2021-03-17
Completion
2021-04-02
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 NCT04606368 on ClinicalTrials.gov