A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
NCT ID: NCT07187297
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
164 participants
INTERVENTIONAL
2025-10-31
2027-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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Control Arm
Treated with Thermage FLX device at day 90
Thermage FLX
The Thermage FLX System ('System') is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures
Treatment Arm
Treated with Thermage FLX device at day 1
Thermage FLX
The Thermage FLX System ('System') is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures
Interventions
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Thermage FLX
The Thermage FLX System ('System') is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures
Eligibility Criteria
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Inclusion Criteria
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 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.
30 Years
60 Years
ALL
Yes
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Locations
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Union Square Laser Dermatology
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TM-PAS-NAPAC-2025-001
Identifier Type: -
Identifier Source: org_study_id