Single-Blind, Investigational Device Exemption Paired-Design, Non-Inferiority Trial With Confirmation for the Assessment of the Efficacy and Safety of a Universal Electrosurgical Device for Temporary Improvement of Mild and Moderate Wrinkles Around Both Eye Corners and Both Cheek Folds

Efficacy and Safety of a Monopolar Radiofrequency Device for the Improvement of Periorbital and Cheek Wrinkles: A Multicenter, Randomized, Single-Blind, Noninferiority Trial

Radiofrequency (RF) devices are commonly used for noninvasive facial rejuvenation. This study compared the efficacy and safety of 10THERMA, a newly developed monopolar RF device, with those of the Thermage FLX system. To determine whether 10THERMA is noninferior to Thermage FLX in improving mild-to-moderate periorbital and cheek wrinkles.

Inclusion Criteria:

• Crow's Feet Grading Scale (CFGS) score of 1-2 at rest (neutral facial expression) for periorbital wrinkles and a Cheek Line Grading Scale (CLGS) score of 1-2 for cheek wrinkles

Exclusion Criteria:

• recent cosmetic procedures, facial malignancy or prior radiotherapy, active dermatologic disease at the treatment site, keloid or abnormal wound healing tendency, immunosuppression, and pregnancy or lactation