A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment to Improve Lines and Wrinkles and to Lift and Tighten Lax Tissue in the Neck, Abdomen, Upper Arms, and Face

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Control Group:On the 90th day, underwent Thermage FL Xtreatment in one or more treatment areas (Area 1, neck; Area 2, abdomen; Area 3, upper arm; Area 4, face);Treatment Group:On the 1st day, underwent Thermage FL Xtreatment in one or more treatment areas (Area 1, neck; Area 2, abdomen; Area 3, upper arm; Area 4, face); CONDITION: Treatment to Improve Lines and Wrinkles and to Lift and Tighten La XTissue in the Neck, Abdomen, Upper Arms, and Face PRIMARY OUTCOME: Evaluate the proportion of subjects who showed any improvement in the iGAIS score on the 90th day. The variable is the iGAIS score of each subject as assessed independently and blindly by the evaluato; SECONDARY OUTCOME: Proportion of participants with any improvement on iGAIS at Day 180 as assessed by independent blinded evaluators.;For abdomen: Improvement on the abdominal skin laxity scale at Day 90 and Day 180;Proportion of participants with any improvement on sGAIS at Day 90 and Day 180.;For face and neck: Improvement on Fitzpatrick Wrinkle Scale at Day 90 and Day 180;For face and neck: Improvement on Facial Laxity Rating Scale at Day 90 and Day 180;For upper arm: Improvement on IBSA Inner Upper Arm Laxity Scale at Day 90 and Day 180; INCLUSION CRITERIA: 1. Be an adult female or male, 30 – 60 years of age; 2. Have mild‐to‐moderate skin laxity of the face, neck, abdomen, and/or upper arms, and/or mild‐to‐moderate lines and/or wrinkles of the face and/or neck assessed as follows: (1) Neck: 1) Mild‐to‐moderate neck skin laxity as defined by a score of 1 to 6 on the 10‐point Facial Laxity Rating Scale (scored 0–9); 2) Mild‐to‐moderate neck wrinkles as defined by a score of 1 to 6 on the 10‐point Fitzpatrick Wrinkle Scale (scored 0–9); (2) Abdomen: 1) Mild‐to‐moderate abdominal skin laxity as defined by a score of 1 or 2 on a 4‐point Abdominal Laxity Scale (scored 0–3); (3) Upper arms: 1) Mild‐to‐moderate upper arm skin laxity as defined by grade 2 or 3 on the 5‐grade IBSA Inner Upper Arm Laxity Scale; (4) Face: 1) Mild‐to‐moderate facial skin laxity as defined by a score of 1 to 6 on the 10‐point Facial Laxity Rating Scale (scored 0–9); 2) Mild‐to‐moderate facial wrinkles as defined by a
Epistemonikos ID: d743e2b3fbe25bdba6a5e6042b4e9c1c34004a53
First added on: Sep 12, 2026