Safety and Efficacy Study of Lidocaine Mixed Hyaluronate on Nasolabial Folds Correction

This clinical trial is a double-blind, randomized, within-subject controlled, 2-armed, single-center study sponsored by SciVision Biotech Inc. and approved by National Taiwan University Hospital Research Ethics Committee. The aim of this post-marketing study is to evaluate the safety and efficacy of Hya-Dermis mixed with lidocaine, as well as the effectiveness of corrections of Hya-Dermis mixed with lidocaine. Accounting for potential loss to follow-up, the minimum enrollment was statistically determined to be 40 patients.

The study was estimated to be held one and half year including a 0-2 weeks screening period, a day of treatment, and follow-up at month 1, 3, 6, 9, 12. Patient informed consent forms will be obtained before the treatment. A pre-treatment photograph, nasolabial folds (NLF) severity scale scores, and individual aesthetic satisfaction will be the baseline. Two sets of randomized numbers are used, patient numbers and treatment numbers. Participants with odd patient numbers will be assigned to nasolabial group and those with even patient numbers will be assigned to nasolabial\&cheekbone group. Participants receive experiment treatment (Hya-Dermis mixed with lidocaine) in one side and control treatment (Hya-Dermis mixed with normal saline) in the other side of the face randomly depending on the treatment numbers. Both physicians and participants are only blind to the treatment assignment. 30 minutes after the injection, a post-photograph will be used to evaluate NLF severity scale scores and global aesthetic improvement scale (GAIS) by physicians. A questionnaire including the Visual Analog Scale (VAS) of pain during the treatment and individual aesthetic satisfaction will be collected from patients. The effectiveness analyses compare NLF severity scale scores and GAIS based on photograph records from physicians, as well as participant questionnaires for each group on every visit. The safety assessment evaluates any recorded adverse events following the device treatment.


Eligibility Criteria:
Inclusion Criteria:

* Be 30 to 60 years of age and of any sex and willing to receive nasolabial folds correction by intradermal injection procedures
* Have ability to understand and comply with the study requirements
* Have approximately symmetrical nasolabial folds with a nasolabial folds severity score of 2-3 and the score difference between two sides is less 1
* Agree to refrain from undergoing other anti-wrinkle treatments in the injective areas 12 months after the injections.
* If female of child-bearing potential, not be breastfeeding, have a negative urine pregnancy test on the treatment day and agree to use any approved contraceptives or medically acceptable method of birth control throughout the study
* Be willing to provide written informed consent prior to any procedures

Exclusion Criteria:

* Have history or active dermal diseases, inflammation, or any related disease, such as infection, psoriasis, and herpes.
* Have history of coagulation defect diseases and still take aspirin, other anti-clotting, or blood activating medications 1 week before the treatments
* Had permanent or semi-permanent implantation on nasolabial areas
* Had dermal-related surgeries history (for example, laser, chemical dermabrasion, fraxel laser, thermocool) 6 months before the treatments.
* Had facial wrinkles and folds corrections (for example, botox or other dermal fillers) 6 months before the study starts
* Have a known history of allergic reactions like hypersensitivity to hyaluronic acid
* Have a known history of allergic reactions to lidocaine other local anesthesia
* Have poor compliance with the study or follow-up schedule