AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Men and women aged between 20 and 70.
✓. Subjects who want to improve bilateral nasolabial folds that are rated as 3 or 4 grades on the WSRS, and same WSRS scores on both sides (both sides are grade 3 or 4 on the WSRS).
✓. Subjects with visually symmetrical bilateral nasolabial folds.
✓. Subjects who are capable of understanding and comply with the study procedures, instructions, and visit schedule.
✓. Subjects who voluntarily decide to participate in the entire course of the trial and provide written consent in the Informed Consent Form.
Exclusion criteria
✕. Subjects who received an anticoagulant, thrombolytic, antiplatelet therapy or other substances are knownto increase coagulation time (e.g., herbal supplements with garlic or ginkgo biloba), or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within 2 weeks prior to screening.
✕Except for low-dose aspirin (100 mg, up to 300 mg/day) or equivalent.
✕. Subjects who received/used a prohibited treatment/procedure as following:
✕. Subjects who received high dose vitamin E (e.g., 400 IU), corticosteroids, or interferon that may interfere with the treatment area or evaluation within 4 weeks prior to screening.
✕. The subject who received soft tissue augmentation as following at the investigational medical device injection site within a certain time frame prior to screening:
✕
What they're measuring
1
The Mean change of the Wrinkle Severity Rating Scale scored by the blinded evaluator.
Previous 6 months with bovine collagen; previous 12 months with porcine or human collagen; previous 18 months with hyaluronic acid or hydroxyapatite.
✕. The subject who received soft tissue augmentation near the injection site with any of the following at any time:
✕Autologous fat, polymethylmethacrylate or other acrylates, polyacrylamide, polyethylene oxide, polylactic acid, permanent expander prosthesis (e.g., soft-form or silicon), or other implant materials.