What is Thermage FLX studying for skin laxity and wrinkles?

Thermage FLX is being studied to see if it can safely improve lines, wrinkles, and looseness of the skin on the neck, abdomen, upper arms, and face. This clinical trial aims to compare this treatment to no treatment to understand its effects. The study is sponsored by Bausch Health Americas, Inc. and involves multiple centers in North America and China.

Who may be eligible for this skin laxity and wrinkle clinical trial?

Adults between 30 and 60 years old with mild to moderate skin laxity or wrinkles on the neck, abdomen, upper arms, or face may be eligible. Both men and women can participate, but women of childbearing potential must use birth control. People with certain recent cosmetic treatments or implanted devices may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this skin laxity and wrinkle clinical trial?

Study-related care, including the use of the Thermage FLX device and all trial visits, is provided at no cost. However, you may have personal travel expenses that vary and are not guaranteed to be covered. Participants should plan accordingly for these potential costs.

Actively Recruiting

Phase Not Applicable

Age: 30Years - 60Years

All Genders

Healthy Volunteers

ID07187297

Study to Test Safety and Effectiveness of Thermage FLX Radiofrequency Treatment for Improving Wrinkles and Tightening Skin on Neck, Abdomen, Upper Arms, and Face

Led by Bausch Health Americas, Inc. · Updated on 2025-12-17

164

Participants Needed

Research Sites

39 weeks

Total Duration

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

Age: 30Years - 60Years

All Genders

Healthy Volunteers

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

Research Team

Sandra Narain

Caitlin Little

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