Wrinkles
Conditions
Keywords
periorbital and cheek wrinkles
Brief summary
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.
Interventions
DEVICE10THERMA
10THERMA : Size of face tip is 5.0 cm2 (Treatment area)
DEVICEThermage FLX
10THERMA : Size of face tip is 4.0 cm2 (Treatment area)
Sponsors
TENTECH INC.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CROW'S FEET GRADING SCALE (CFGS) | 16weeks | 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. |
| CHEEK Line GRADING SCALE (CLGS) | 16weeks | 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. |
Countries
South Korea
Outcome results
None listed