Actively Recruiting
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
Led by Bausch Health Americas, Inc. · Updated on 2025-12-17
164
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of the Thermage FLX System, a device designed to improve lines and wrinkles and lift and tighten loose skin in adults aged 30 to 60 years. The study is a prospective, randomized, multicenter trial conducted at approximately 10 sites in North America and China. It focuses on mild-to-moderate skin laxity and wrinkles on the neck, abdomen, upper arms, and face. Participants are randomly assigned to receive treatment with the Thermage FLX device either on day 1 or day 90. The study compares treated participants with an untreated control group to assess improvements in skin appearance. The treatment involves a non-invasive radiofrequency procedure designed for dermatological use. During the 6-month (26-week) study, participants will attend scheduled visits for assessments by independent blinded evaluators. Researchers will measure the primary outcome at 90 days and secondary outcomes at 180 days after treatment. Safety, tolerability, and skin improvements will be closely monitored through various clinical evaluations and participant follow-up throughout the study period.
CONDITIONS
Brief Title
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be an adult female or male, aged 30 to 60 years
- Have mild-to-moderate skin laxity or lines and wrinkles of the neck, abdomen, upper arms, and/or face as defined by specific rating scales
- Females of childbearing potential must have a negative urine pregnancy test
- Females of childbearing potential must agree to use an acceptable method of birth control during the study
- Have no clinically abnormal findings based on medical history
- Be able to follow study instructions, attend required visits, and complete all assessments
- Understand the research nature of the study and sign informed consent
- Agree to avoid energy-based device treatments, injectables, or plastic surgery on study areas during the study
- Have a body mass index (BMI) of 30 or less
You will not qualify if you...
- Pregnant, breastfeeding, or trying to become pregnant within 3 months prior to screening or during the study
- Given birth within 3 months prior to screening
- Anticipated need for procedures, surgery, hospitalization, or events preventing required visits
- Have a pacemaker, internal defibrillator, or other implanted electronic device
- Have an implant in the target treatment zones
- Have had radiation therapy in target treatment zones
- Had prior cosmetic procedures in target zones within specified timeframes including Thermage, energy-based devices, derm abrasion, chemical peels, neurotoxins, fillers, or plastic surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 180 days
Participants receive treatment with the Thermage FLX device to improve skin laxity and reduce lines and wrinkles in target areas.
1 visit for treatment at day 1 or day 90 depending on group assignment and follow-up visits
Duration - Up to 180 days
Participants are monitored for safety and effectiveness of the Thermage FLX treatment over time.
Follow-up visits to assess outcomes up to 180 days post-treatment
Trial Site Locations
Total: 1 location
1
Union Square Laser Dermatology
New York, New York, United States, 10003
Actively Recruiting
Research Team
S
Sandra Narain
C
Caitlin Little
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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