Thermage FLX: The Thermage FLX System ('System') is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures
Study summary
A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System
Eligibility
Sex
ALL
Min age
30 Years
Max age
60 Years
Healthy volunteers
Accepted
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.
Exclusion Criteria:
* Participant is pregnant or breast feeding or trying to become pregnant for 3 months prior to the screening visit or during the study.
Participant has given birth within 3 months prior to the screening visit.
Participant has an anticipated need for procedures, surgery, overnight hospitalization, or other events that would prevent the participant from making the required visits during the study.
Participant has a pacemaker, internal defibrillator, or other implanted electronic device.
Participant has an implant in the target treatment zone(s).
Participant has had radiation therapy in the target treatment zone(s).
Participant has had 1 or more prior cosmetic procedures in the target treatment zone(s) including:
Thermage or any energy-based device procedure, derm abrasion, or chemical peel on any treatment area within 6 months prior to the screening visit.
Short-acting neurotoxins within 6 months prior to the screening visit.
Long-acting neurotoxins within 9 months prior to the screening visit.
Hyaluronic acid filler ≤1 year prior to the screening visit.
Semi-permanent or permanent fillers at any time prior to the screening visit.
Plastic surgery within 1 year prior to the screening visit.
Primary outcome measure(s)
Primary Endpoint — 90 days Proportion of participants with any improvement on iGAIS at Day 90 as assessed by independent blinded evaluators.
Trial sites (7)
Facility
City
Region
Status
Laser & Skin Surgery Center of Northern California
Sacramento
California
Recruiting
Cosmetic Laser Dermatology
San Diego
California
Recruiting
Cosmetic Laser Dermatology
San Diego
California
Recruiting
Chicago Cosmetic Surgery and Dermatology
Chicago
Illinois
Recruiting
SkinCare Physicians
Chestnut Hill
Massachusetts
Recruiting
Union Square Laser Dermatology
New York
New York
Recruiting
Dermatology and Laser Surgery Center
Houston
Texas
Recruiting
More Bausch Health Americas, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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