A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment

Inclusion Criteria

• •Be an adult female or male, ≥30 - ≤60 years of age.
• •Have mild-to-moderate skin laxity of the neck, abdomen, upper arms, and/or face, and/or mild-to-moderate lines and/or wrinkles of the neck and/or face assessed as follows:
• •Neck:
• •Mild-to-moderate neck skin laxity as defined by a score of 1 to 6 on the 10-point Facial Laxity Rating Scale (scored 0-9)
• •Mild-to-moderate neck wrinkles as defined by a score of 1 to 6 on the 10-point Fitzpatrick Wrinkle Scale (scored 0-9)
• •Abdomen:
• •Mild-to-moderate abdomen skin laxity as defined by a score of 1 or 2 on a 4-point Abdominal Laxity Scale (scored 0-3)
• •Upper arms:
• •Mild to moderate upper arms skin laxity as defined by grade 2 or 3 on the 5-grade IBSA Inner Upper Arm Laxity Scale
• •Face:
• •Mild-to-moderate facial skin laxity as defined by a score of 1 to 6 on the 10-point Facial Laxity Rating Scale (scored 0-9)
• •Mild-to-moderate facial wrinkles as defined by a score of 1 to 6 on the 10-point Fitzpatrick Wrinkle Scale (scored 0-9)
• •Females of childbearing potential must have a negative urine pregnancy test. Females who have experienced menarche and who are not postmenopausal (either confirmed via FSH testing or who have not menstruated for 2 years or more without an alternative medical cause) or surgically sterile will be considered of childbearing potential.
• •Females of childbearing potential must agree to use an acceptable method of birth control for the duration of the study. Acceptable methods of birth control are oral and other systemic contraceptives, condoms only, intrauterine device, double-barrier methods, bilateral tubal ligation, partner vasectomy, and abstinence.
• •Have no clinically abnormal findings based on the medical history as determined by the study investigator.
• •Be able to follow the study instructions, be available on the specific required study visit days, and be willing to complete all study visit procedures and assessments.
• •Understand the research nature of this study and sign an informed consent document prior to the performance of any study-specific procedure or assessment.
• •Agree to not undergo excluded procedures (i.e., energy-based device treatments, injectables, or plastic surgery) on the study treatment areas for the duration of study.
• •Participant has a body mass index (BMI) ≤30.