Pivotal Study to Evaluate the Efficacy and Safety of Injection with SkinPlus-HYAL Implant Lidocaine as Compared to RESTYLANE Lidocaine in temporary Correction of Nasolabial folds
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0008113
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wrinkle Severity Rating Scale (Assessed by Independent Central Reviewer)
- Secondary Outcome Measures
Name Time Method 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