None listed
Conditions
Interventions
None listed
Sponsors
Biostandard
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Among those who want to improve both nasal and lip wrinkles(nasolabial fold), those who have a Wrinkle Severity Rating Scale (WSRS) of 3 or 4 points. 2. Both nasal and lip wrinkles(nasolabial fold) are visually symmetrical. 3. A person who has agreed to discontinue any dermatological treatment or treatment, including facial wrinkle improvement, during this clinical trial period. 4. A person who voluntarily decides to participate in this clinical trial and agrees in writing to the "Informed Consent Form".
Exclusion criteria
Exclusion criteria: *Exclusion Criteria: (Subjects who meet any of the following conditions cannot participate in this study) 1. Those who have skin hypersensitivity to the clinical trial medical device as a result of the intradermal reaction test at the time of screening 2. Those who have taken anticoagulant (excluding low-dose aspirin (100mg, max. 300mg/day)) or nonsteroidal anti-inflammatory drugs within 2 weeks of screening 3. Those with abnormal liver function or blood coagulation, or who need to take antithrombotic drugs (excluding low-dose aspirin (100mg, maximum 300mg/day)) during the clinical trial 4. Those who have used topical coating agents (steroids, retinoids: drugs only, excluding cosmetics) on the face within 4 weeks from the screening date, or plan to continue using them during the clinical trial period. 5. Those who received wrinkle improvement or acne treatment within 6 months from the screening date 6. Those who received wrinkle improvement treatment using collagen or HA filler within 6 months from the screening date, or had undergone facial acne treatment, dermabrasion, skin regeneration, or plastic surgery (including Botox injection) 7. Those who received CaHA (Calcium HydroxyApatite) treatment at the site where the clinical trial medical device was applied within 1 year from the screening date. 8.A person who has inserted a permanent skin expansion implant such as softform or silicone on the face 9. A person who has not treated a scar that requires treatment on the face for more than 1 year, or has a scar or a mark on the application site of this clinical trial medical device 10. Persons with a history of anaphylaxis or severe allergy symptoms 11. Those with a history of hypertrophic scars or keloids 12. Those who have had side effects with EMLA Cream in the past (exclusion criteria not applied to subjects who will not use EMLA cream) 13. Those with facial skin diseases or wound infections that affect this clinical trial 14. Those with reduced immunity 15. Those who have clinically serious disorders in the cardiovascular system, digestive system, respiratory system, endocrine system, central nervous system, or have had or currently have mental disorders that have a significant effect on this clinical trial 16. Those who participated in other clinical trials within 30 days of screening 17. Among female subjects who are likely to become pregnant during the clinical trial, those who do not agree to use a medically acceptable method of contraception (Contraception: Medically accepted method of contraception: condoms, oral contraceptives lasting for at least 3 months, use of injectable or implantable contraceptives, with intrauterine contraceptives installed, etc.) 18. Pregnant or lactating women 19. In addition to the above, a person who has clinically significant findings deemed inappropriate for this test as it is medically judged by the principal or responsible person 20. Patients with hypersensitivity to lidocaine or amide type local anesthetics 21. Patients with bleeding disorders or taking thrombolytics or anticoagulants 22. Those with hypersensitivity to hyaluronic acid 23. Those with a history of autoimmune diseases 24. Those who use cosmetics for wrinkle improvement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Average value of the Wrinkle Severity Rating Scale (WSRS) of the test group and control group evaluated by the “independent evaluator” at 24 weeks after the final application of the “Clinical Investigational Device”;2. Average value of Visual Analogue Scale (VAS) of the test group and control group within 60 minutes after the final application of the clinical trial medical device;3. The average value of the Wrinkle Severity Rating Scale (WSRS) of the test group and control group evaluated by an independent evaluator at 8 weeks after the final application of the medical device;4. The average value of the Wrinkle Severity Rating Scale (WSRS) of the test group and control group evaluated by the investigator at 8 and 24 weeks after the final application of the medical device;5. Average value of Global Aesthetic Improvement (GAIS) of the test group and control group evaluated by "investigator" and "subject" at 8 and 24 weeks after the final application of the medical device compared to before the first application of the medical device;6. The proportion of "subjects" whose difference between the test group and the control group's Wrinkle Severity Rating Scale (WSRS) is at least 1 point, respectively, from baseline to 24 weeks after the last application of the medical device evaluated by the "independent evaluator";7. The proportion of subjects whose difference between the test group and the control group's Wrinkle Severity Rating Scale (WSRS) is at least 1 point, respectively, from baseline to 24 weeks after the final application of the medical device evaluated by the investigator;8. Safety - Adverse Event / Clinical Laboratory Results / Vital Signs Results | — |
Countries
Korea, Republic of
Contacts
Public ContactJONG HUN LEE
Eulji University Medical Center
Outcome results
None listed