A multi-center, single-arm clinical study for the efficacy and safety of '10THERMA' on tissue coagulation and skin rejuvenatio
- Conditions
- Factors influencing health status and contact with health services
- Registration Number
- KCT0008709
- Lead Sponsor
- Korean Society for Laser Medicine and Sugery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 31
1) Adults between the ages of 30 and 70
2) Those who meet all of the following wrinkle scales
- Those who want temporary improvement of both crow's feet and those who have a resting (expressionless) Crow's Feet Grading Scale of 1-2 points
- Those who want temporary improvement of cheek wrinkle and have a cheek line grading scale of 1-2 points
3) Those who agree to stop all dermatological treatments or treatments, including wrinkle improvement of the facial area, during this clinical trial
4) Those who agree to take a picture of the facial area, including the eye area
5) Those who voluntarily decide to participate in this clinical trial and agree to the subject consent form in writing
1) Those who have undergone cosmetic treatment such as laser, phototherapy, or surgery on the face within the last 6 months, or have undergone filler treatment using collagen, hyaluronic acid filler, or other materials
2) Those who have received radiotherapy in the facial area or have a history of chemotherapy and a history of malignant tumors
3) Those who have a history of infection, dermatitis, rash and heat-stimulated diseases such as herpes simplex and herpes zoster (including severe acne, fever or light, various allergies to beauty products, etc.), and those who have used steroid drugs
4) Those who have a history of keloid scarring, hypertrophic scarring, and abnormal wound healing
5) Those who have used whitening agents (Hydroquinone, Tranexamic acid, etc.), Isotretinoid (or Retinoid), light-sensitive drugs, and steroid drugs within the last 6 months
6) Women who are pregnant and breastfeeding (those who plan to become pregnant during the clinical trial or do not agree to appropriate contraceptive methods)
7) Other investigators judged to be inappropriate for this clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparing and evaluating the degree of improvement of cheek wrinkles using photographs of the subjects at week 4
- Secondary Outcome Measures
Name Time Method Evaluation of the degree of improvement of cheek wrinkles at week 4 and 16 after application of medical devices, evaluation of the Global Aesthetic Improvement Scale by the investigator and subject, and evaluation of the degree of improvement of the wrinkle/texture index