Thermage FLX for Skin Tightening
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a skin-tightening treatment called Thermage FLX to evaluate its effectiveness in tightening skin and reducing wrinkles. The study compares two groups: one receives early treatment, and the other receives later treatment. It seeks men and women aged 30 to 60 with mild-to-moderate sagging or wrinkles on the neck, face, abdomen, or arms. Participants should have a BMI of 30 or less and must agree not to undergo any cosmetic procedures in those areas during the study. As an unphased trial, this study allows participants to contribute to research that could lead to new cosmetic treatment options.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on cosmetic procedures and certain medical devices as exclusions.
What prior data suggests that the Thermage FLX device is safe for skin tightening?
Research has shown that Thermage FLX, a device for tightening skin, is generally safe when used properly. Studies have found that this radiofrequency (RF) technology is effective for non-surgical skin treatments. However, awareness of possible side effects is important.
Some reports indicate that overusing Thermage FLX might lead to issues like dents in the skin or changes in facial shape. Another concern is tissue arcing, which can occur if the device is not used correctly and might cause scarring.
Overall, while Thermage FLX is usually well-tolerated, trained professionals must operate the device to reduce risks.12345Why are researchers excited about this trial?
Researchers are excited about Thermage FLX for skin tightening because it non-invasively uses radiofrequency energy to stimulate collagen production, which can result in firmer, smoother skin. Unlike surgical options like facelifts, Thermage FLX offers a convenient, non-surgical alternative with minimal downtime. This treatment is also distinct in its ability to target specific skin areas precisely, allowing for customized treatments that suit individual needs.
What evidence suggests that the Thermage FLX device is effective for skin tightening?
Research has shown that the Thermage FLX system effectively tightens skin on the face, neck, and eyelids. Noticeable improvements have appeared in areas like sagging jawlines and nasolabial folds. A recent study found that dermatologists rated Thermage FLX as 57.4% more effective than other treatments. The system uses radiofrequency energy to boost collagen production, tightening and firming the skin. Patients often notice results immediately, with further improvements over the next six months.
In this trial, participants in the Treatment Arm will receive the Thermage FLX treatment on day 1, while those in the Control Arm will receive the treatment on day 90.678910Are You a Good Fit for This Trial?
This trial is for adults aged 30-60 with a BMI ≤30, who have mild-to-moderate skin laxity or wrinkles on the neck, abdomen, upper arms, or face. Participants must follow study instructions and visit schedules, not undergo excluded procedures during the study, and women of childbearing age must use birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Thermage FLX treatment. The treatment arm is treated on Day 1, and the control arm is treated on Day 90.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at Day 90 and Day 180.
What Are the Treatments Tested in This Trial?
Interventions
- Thermage FLX
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bausch Health Americas, Inc.
Lead Sponsor
Dr. Jonathan Sadeh
Bausch Health Americas, Inc.
Chief Medical Officer
MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School
Thomas J. Appio
Bausch Health Americas, Inc.
Chief Executive Officer since 2021
Bachelor's degree in Biology from Rutgers University