A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thermage FLX.
- Who it may be relevant to
- Registry conditions: Wrinkle, Lax Skin, Lines Skin. Basic parameters: 30 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment to Improve Lines and Wrinkles and to Lift and Tighten Lax Tissue in the Neck, Abdomen, Upper Arms, and Face
Overview
A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System
Detailed description
Study to be conducted at approximately 10 study centers, enrolling a total of 164 participants in North America (US and Canada) and China. Approximately 6 months (26 weeks) Purpose is to demonstrate superiority of treatment with the Thermage FLX System compared to untreated control for the improvement of:
Lines and wrinkles of the neck and face Skin laxity of the neck, abdomen, upper arms, and face and evaluate safety and tolerability of treatment with the Thermage FLX System compared to the untreated control arm.
Interventions
- Device Thermage FLX
The Thermage FLX System ('System') is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures
Primary outcome measures
- Primary Endpoint [Time frame: 90 days]
Secondary outcome measures (1)
- Secondary Endpoint [Time frame: 180 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Union Square Laser Dermatology — New York
Identifiers
NCT: NCT07187297 · TM-PAS-NAPAC-2025-001