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
Trial Overview
The Thermage FLX System is being tested over a 180-day period to see if it can improve lines and wrinkles and tighten lax tissue in the neck, abdomen, upper arms, and face. The study is randomized with independent evaluators at multiple centers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Treated with Thermage FLX device at day 1
Treated with Thermage FLX device at day 90
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
Citations
Evaluation of Improvement in Skin Laxity and Oiliness After ...
Significant improvements in jawline sagging and nasolabial folds were observed in 2D/3D images. Quantitative analysis confirmed RF‐induced skin ...
Thermage FLX System to Treat the Face, Neck, and Eyelids
Thermage FLX system for the correction of mild to moderate laxity of the skin of the face, neck, and eyelids. What is the study measuring? Primary Outcome ...
The In-Office Treatment That Builds Long-Lasting Collagen
According to one recent scientific analysis that looked at 52 surveys among dermatologists, Thermage FLX was considered 57.4% more effective ...
A survey on monopolar radiofrequency treatment: The ...
According to a total of 52 surveys analyzed, this latest device (Thermage FLX) was considered more effective (57.4%), faster with reduced ...
5.
phukethospital.com
phukethospital.com/healthy-articles/the-non-surgical-solution-for-skin-tightening-thermage-flx/The Non-Surgical Solution for Skin Tightening (Thermage ...
Short treatment consuming time ranging from 30-90 minutes. There may be an immediate result with continued improvement over the next 6 months.
A Prospective Controlled Study to Evaluate the Safety and ...
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 ...
Side effects of Thermage FLX - Ai Beauty Clinic
Thermage FLX requires a high standard of operational technique. Too many treatments may cause skin depression, damage to face contour and face collapse.
8.
medicaldevicenavigator.com
medicaldevicenavigator.com/thermage_flx_study_safety_efficacy_skin_rejuvenation/New Clinical Trial to Assess Safety and Efficacy of Thermage ...
Clinical testing on the Thermage® FLX device is set to evaluate its safety and effectiveness in treating skin laxity and wrinkles.
Update on Tissue Tightening - PMC
A major adverse event noted with these RF devices is known as tissue arcing, which can lead to scar formation. This has been noted when the hand piece has not ...
Is Thermage Safe? Exploring RF Skin Tightening Technology
Numerous clinical studies confirm that RF technology, including Thermage, is safe for non-invasive skin tightening when used correctly.
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