A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System
Study to be conducted at approximately 10 study centers, enrolling a total of 164 participants in North America (US and Canada) and China. Approximately 6 months (26 weeks) Purpose is to demonstrate superiority of treatment with the Thermage FLX System compared to untreated control for the improvement of: Lines and wrinkles of the neck and face Skin laxity of the neck, abdomen, upper arms, and face and evaluate safety and tolerability of treatment with the Thermage FLX System compared to the untreated control arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
164
The Thermage FLX System ('System') is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures
Union Square Laser Dermatology
New York, New York, United States
RECRUITINGPrimary Endpoint
Proportion of participants with any improvement on iGAIS at Day 90 as assessed by independent blinded evaluators.
Time frame: 90 days
Secondary Endpoint
Proportion of participants with any improvement on iGAIS, Fitzpatrick Wrinkle Scale, Facial Laxity Rating Scale, IBSA Inner Upper Arm Laxity Scale, Abdominal Laxity Scale at Day 90 and 180.
Time frame: 180 days
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