Wrinkle
Conditions
Keywords
Tissue restorative biomaterial, Hyaluronic acid, Restylane®, Wrinkle Severity Rating Scale (WSRS), Global Aesthetic Improvement Scale (GAIS), Nasolabial fold(NLF)
Brief summary
\- Study design:Multi-center, randomized, double-masked (Unblinded treating investigators), intra-individual comparison clinical trial
Detailed description
* Subjects:Adults with nasolabial fold * Investigational Devices: Study Device: SkinPlus-Hyal® Comparator Device: Restylane® \- Procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the WSRS of his/her nasolabial fold wil be evaluated by the Investigator Treatment: The Injector will administer to the eligible subject the Study Device and Comparator Device respectively to the left and right nasolabial fold in a randomized manner. Post-Treatment: All subjects will visit the hospital at 2, 8, 16, 24 weeks since the day of administration, and will take pictures of the Nasolabial fold area and undergo efficacy and safety evaluation during each visit. The Photographic evaluator will evaluate the efficacy
Interventions
DEVICESkinPlus-Hyal®
The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner.
DEVICERestylane®
The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner.
Sponsors
HumanTissueKorea Ltd.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Men and women aged over 20 2. Subjects who want to correct his/her nasolabial fold and have point 3 or 4 in WSRS of nasolabial fold and visually symmetric 3. Subjects who voluntarily decided the participation of the study and signed the informed consent 4. Subjects who agree contraception
Exclusion criteria
1. Subjects who had anaphylaxis or a severe combined allergy, or an allergy to hyaluronic acid 2. Subjects who had eczema, infection, psoriasis, sclerosis, acne on the face 3. Subjects who have a skin disorder on the NLF area 4. Subjects who had permanent implants for dermal augmentation at the NLF area 5. Subjects who had a history of keloid formation or hypertrophic scar 6. Subjects who participated in other clinical trial within 3 months from screening date 7. Female subjects of childbearing potential who disagreed with medically acceptable contraception (e.g., condom, oral contraceptives continuing at least 3 months, injectable or insertable contraceptives, intrauterine contraceptive devices) during the trial 8. Subjects who is Drug abuser or alcoholism 9. Subjects who had previous treatment with Botox within 6 months from screening date 10. Subjects who had previous treatment for wrinkle with Retin-A within 1 months from screening date 11. Subjects who had previous treatment with tissue restorative biomaterials within 18 months from screening date 12. Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator 13. Subjects who had antigen of HIV or type-B Hepatitis 14. Subjects who had anti-coagulant therapy within 2 weeks from the screening date 15. Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in WSRS of the test group and control group | Baseline and 24 weeks | The change in WSRS of the test group and control group from baseline at 24 weeks as assessed by the Investigator in charge of photographic assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in WSRS of the test and control groups | baseline and 2, 8, 16, 24 weeks | The change in WSRS of the test and control groups from baseline at 2, 8, 16, 24 weeks as assessed by the Investigator |
Other
| Measure | Time frame | Description |
|---|---|---|
| The percentage of subjects whose GAIS is 1 point or above | 2, 8,16, 24 weeks | The percentage of subjects whose GAIS is 1 point or above at 2, 8, 16, 24 weeks after injection as assessed by the Investigator |
Countries
South Korea
Outcome results
None listed