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

TENTECH INC.80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Wrinkles

Interventions

10THERMADEVICE

10THERMA : Size of face tip is 5.0 cm2 (Treatment area)

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Deokan, South Korea

Severance Hospital

Seoul, Seodaemungu, South Korea

Asan Medical Center

Seoul, Songpagu, South Korea

Outcomes

Primary Outcomes

CROW'S FEET GRADING SCALE (CFGS)

CROW'S FEET GRADING SCALE (CFGS) To assess wrinkle improvement in each area around the eyes, the CFGS will be administered at baseline, at Week 4, and at Week 16. At baseline, the CFGS will be administered prior to application of the investigational device. Each wrinkle scale will be assessed by the investigator and an independent evaluator, who will use photographs of the area where the investigational device was applied taken at each time point, excluding screening. In the case of evaluation by the examiner, photographs are not used and evaluation is made through direct observation during the examination. The resting (neutral expression) CROW'S FEET GRADING SCALE (CFGS) score according to the degree of wrinkles is composed of 0 points (Absent : no wrinkles), 1 point (Mild : very fine wrinkles), 2 points (Moderate : fine wrinkles), 3 points (Severe : moderate wrinkles), and 4 points (Extreme : severe wrinkles), with a lower score indicating the absence of wrinkles.

Time frame: 16weeks

CHEEK Line GRADING SCALE (CLGS)

The Cheek Line Grading Scale (CLGS) will be administered at screening, baseline, weeks 4, and 16 to assess wrinkle improvement in each cheek area. The baseline assessment will be conducted prior to application of the clinical trial device. Each wrinkle scale will be assessed by the investigator and an independent evaluator, who will use photographs of the clinical trial device application site taken at each time point, excluding screening. In the case of evaluation by the examiner, photographs are not used, and evaluation is made through direct observation during the examination. The Cheek Line Grading Scale (CLGS) according to wrinkle severity is composed of 0 points (no wrinkles), 1 point (Minimal : 1\~2 superficial lines), 2 points (Moderate : 3\~5 superficial lines), 3 points (Severe : Greater than 5 superficial lines; no crosshatching), 4 points (Diffuse : Diffuse superficial lines; crosshatching), with a lower score indicating an absence of wrinkles.

Time frame: 16weeks