Actively Recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Led by Bausch Health Americas, Inc. · Updated on 2025-12-17
164
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System
CONDITIONS
Official 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 on the neck, abdomen, upper arms, and/or face as assessed by specified scales
- Females of childbearing potential must have a negative pregnancy test and agree to use 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 assessments
- Understand the study and sign informed consent
- Agree not to undergo excluded cosmetic procedures on treatment areas during the study
- Have a body mass index (BMI) of 30 or less
You will not qualify if you...
- Are pregnant, breastfeeding, or trying to become pregnant within 3 months before screening or during the study
- Have given birth within 3 months before screening
- Anticipate needing surgery, hospitalization, or other events preventing study visits
- Have a pacemaker, internal defibrillator, or other implanted electronic device
- Have an implant in the target treatment areas
- Have had radiation therapy in the target treatment areas
- Had cosmetic procedures in the target areas recently, including Thermage or energy-based treatments within 6 months
- Had short-acting neurotoxins within 6 months or long-acting neurotoxins within 9 months before screening
- Had hyaluronic acid fillers within 1 year or any semi-permanent/permanent fillers before screening
- Had plastic surgery within 1 year before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
C
Caitlin Little
CONTACT
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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