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

NCT ID: NCT04606368

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-29
• Study Completion Date: 2021-04-02

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional cohort

Each subject will serve as their own control. Left side of lower jaw and submental area is control side. Right side of subject's lower jaw and submentum area will receive treatment.

Group Type: EXPERIMENTAL

Thermage FLX

Intervention Type: DEVICE

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

Interventions

Thermage FLX

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Female subjects > 40 years of age and < 80 years of age.
• Presence of mild to moderate skin laxity on lower face and submentum area, which in the investigator's opinion may benefit from monopolar radiofrequency to improve the skin laxity for a youthful, rejuvenated appearance.
• BMI under 35.
• Agreement to maintain their weight within 5 lb of the baseline.
• Subject has read and signed a written informed consent form.

Exclusion Criteria

• Subject has severe skin laxity in the area of intended treatment which in the opinion of the investigator, may result in an unacceptable aesthetic result.
• Subject has had a surgical procedure(s) in the area of intended treatment.
• History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), in or around the area of intended treatment.
• Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
• Currently taking or has taken diet pills or weight control supplements within the past month.
• Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
• Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
• Pregnant or intending to become pregnant in the next 6 months.
• Lactating or has been lactating in the past 6 months.
• BMI ≥ 35.
• Unable or unwilling to comply with the study requirements.
• Currently enrolled in a clinical study of any other unapproved investigational drug or device.
• Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Solta Medical

INDUSTRY

Sponsor Role: collaborator

Lorraine Hickson

OTHER

Sponsor Role: lead

Responsible Party

Lorraine Hickson

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Leyda R Bowes, MD

Role: PRINCIPAL_INVESTIGATOR

Riverchase Dermatology

Locations

Riverchase Dermatology

Miami, Florida, United States

Countries

United States

Other Identifiers

Bausch Health 2019-4816

Identifier Type: -

Identifier Source: org_study_id