Clinical trial NCT04606368: Bausch Health Thermage FXL for Use on Lower Face and Submentum Area
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Wrinkling
Lead sponsor: Riverchase Dermatology
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
name: Solta Medical
First posted: 2020-10-28
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-center, non-randomized, interventional cohort study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of treatment-emergent Adverse Events [Safety and Tolerability]
timeFrame: 12 weeks
Secondary outcomes:
measure: Subjective clinical evaluation of skin laxity with the use of monopolar radiofrequency treatment on lower face and neck [Efficacy]
timeFrame: up to 12 weeks
measure: Subject satisfaction of skin laxity treatment on lower face and submentum areas documented in written questionnaire
timeFrame: though study completion, up to 12 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Riverchase Dermatology
state: Florida
Study officials:
affiliation: Riverchase Dermatology
name: Leyda R Bowes, MD
role: PRINCIPAL_INVESTIGATOR
References: