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

NCT04606368 | Completed FDA Device

• 1 other identifier: Bausch Health 2019-4816
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Wrinkling

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent Adverse Events [Safety and Tolerability]

  The primary objective of this study is to evaluate the safety and efficacy of improvement of skin laxity with the use of monopolar radiofrequency (Thermage FLX, Solta Medical) on lower face and submentum areas. Safety is defined as incidence of device- and/or procedure-related adverse events. Qualitative measurement of efficacy by independent blinded evaluators grading randomized baseline and 3 months follow-up photographs using a 4-point skin laxity rating scale.

  12 weeks

Secondary Outcomes (2)

• Subjective clinical evaluation of skin laxity with the use of monopolar radiofrequency treatment on lower face and neck [Efficacy]

  up to 12 weeks

• Subject satisfaction of skin laxity treatment on lower face and submentum areas documented in written questionnaire

  though study completion, up to 12 weeks

Study Arms (1)

Interventional cohort

EXPERIMENTAL

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.

Device: Thermage FLX

Interventions

Thermage FLX DEVICE

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

Interventional cohort

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lorraine Hickson: lead
• Bausch Health Americas, Inc.: collaborator
• Solta Medical: collaborator

Study Sites (1)

Riverchase Dermatology

Miami, Florida, 33133, United States

Location

Study Officials

• Leyda R Bowes, MD

  Riverchase Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: Prospective, single-center, non-randomized, interventional cohort study

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 28, 2020
• Study Start: September 29, 2020
• Primary Completion: March 17, 2021
• Study Completion: April 2, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)