None listed
Conditions
Interventions
Medical Device : 1) Screening
All subjects who have signed the Informed consent form are sequentially assigned a screening number during the screening visit to determine whether the criteria for inclu
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women over 19 years of age 2. Subject who want to temporarily improve both nasolabial folds have a Wrinkle Severity Rating Scale (WSRS) of 3 or 4 points (both do not need to be the same score) 3. Subject who has agreed to discontinue all dermatological treatments or treatments (filler, botulinum toxin, laser treatment, chemical exfoliation, cosmetic surgery, etc.) including the improvement of wrinkles in the face area during this clinical trial 4. Subject who can understand and follow the instructions and participate in the entire clinical trial period 5. Subject who voluntarily decides to participate in this clinical trial and agrees in writing to the informed consent form
Exclusion criteria
Exclusion criteria: 1. Subject who administered anti-thrombotic drugs (excluding low-dose aspirin (100 mg, up to 300 mg/day) from 2 weeks before to 2 weeks after application of Investigational devices for clinical trials, and vitamin E and NSAID drugs from 1 week before application 2. Subject who has a medical history of bleeding at a past or present time 3. Subject who has received CaHA (calcium hydroxyapatite) or PLLA (poly L-lactide) filler treatment at the Investigational device application area for clinical trials within one year from the date of screening 4. Subject who have used local applicants (steroids, retinoids: medicines only, not cosmetics) on the face within 4 weeks of the screening date or who are scheduled to use them during the clinical trial period (However, steroid ointment can be used for a short period of time within 14 consecutive days) 5. Subject who have used immunosuppressants, chemotherapy agents, or systemic corticosteroids within 12 weeks of screening date 6. Subject who has received treatment for wrinkle improvement or acne scars within 24 weeks from the date of screening 7. Subject who has undergone an epidermis, skin regeneration, or plastic surgery (including botulinum toxin injection) on the face within 24 weeks from the date of screening 8. Subject who insert permanent skin extension prosthesis such as soft form or silicone into the face 9. Subject who has a skin disease or wound infection in the face area that affects this clinical trial 10. Subject with a medical history of autoimmune diseases 11. Subject who overreact to sodium hyaluronate 12. Subject with streptococcal disease 13. Subject who has experienced anaphylaxis or severe allergic symptoms 14. Subject who has a medical history of hypertrophic scarring, hyperpigmentation, or keloid 15. Subject with hypersensitivity to lidocaine or other amide-based local anesthetic 16. Subject with blood clotting disorder 17. Subject who has had or currently has a mental illness that has significant clinical disabilities in the cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system 18. Subject who participates in another clinical trial within 30 days from the date of screening and administers/applied Investigational devices for clinical trials 19. Among female subjects who are likely to be pregnant, those who do not agree to use contraception* by medically permitted methods up to 48 weeks after the application of Investigational devices in this clinical trial *Medically acceptable contraceptive methods: condoms, oral contraceptives that last at least three months, injections or implantable contraceptives, and intrauterine contraceptives installed, etc 20. Pregnant or lactating women 21.Subject who uses steroids for the purpose of treatment (immunity disease, musculoskeletal disease, etc.) within 4 weeks of participation in the test or plans to use them during the test period 22. Subject who use functional cosmetics that improve wrinkles within 4 weeks of participation in the test or who plan to use them during the test period 23. In addition to the above, Principal Investigator or Investigator has clinically significant findings that are medically deemed inappropriate for this test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkle Severity Rating Scale (Assessed by Independent Central Reviewer) | — |
Secondary
| Measure | Time frame |
|---|---|
| Wrinkle Severity Rating Scale difference in average value (Assessed by Independent Central Reviewer);Wrinkle Severity Rating Scale difference in average value (Assessed by Investigator);Global Aesthetic Improvement Scale difference in average value (Assessed by Investigator);Global Aesthetic Improvement Scale difference in average value (Assessed by Subject);Percentage of subjects whose Wrinkle Severity Rating Scale score improved by 1 point or more (Assessed by Independent Central Reviewer);Percentage of subjects whose Wrinkle Severity Rating Scale score improved by 1 point or more (Assessed by Investigator);The difference in average value of the the Pain VAS difference between the test group and the control group (Assessed by Subject);The percentage of subjects whose pain VAS difference between the test group and the control group is at least 10 mm | — |
Countries
Korea, Republic of
Contacts
Public ContactEungjae Jun
Bioplus
Outcome results
None listed