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Completed

NCT Number: NCT04606368

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

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.

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Key information

Conditions

Skin Wrinkling

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riverchase Dermatology

Miami, Florida, 33133, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thermage FLX

Device

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

Primary outcomes

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

    Time frame: 12 weeks

    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.

Secondary outcomes

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

    Time frame: up to 12 weeks

    Quantitative measurement of efficacy by standardized 2-D and 3-D images with volume difference in cc, height difference in mm, and surface area reduction measures calculations in cm2 using VECTRA H2 (Canfield Scientific, Inc), as well as, by histochemistry evaluation of punch biopsies performed at baseline, 4 weeks and 12 weeks post-procedure.

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

    Time frame: though study completion, up to 12 weeks

    Subject satisfaction data will be collected at the 12-week final follow-up visit via a written questionnaire. A validated questionnaire using a likert rating scale will be utilized . Score values are 1 to 5, with high numbers meaning better outcomes.

Sponsors and collaborators

Lead sponsor

Lorraine Hickson

Other

Collaborators

  • Bausch Health Americas, Inc.
  • Solta Medical

Registry information

Official study title

Evaluation of the Safety and Efficacy of Sequential Use of Monopolar Radiofrequency Treatment on Lower Face and Submental Area for Fat Reduction and Improvement of Skin Laxity

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2020
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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