Evaluate the Efficacy and Safety of PavéDerm J-Fill Soft Dermal Filler vs. Restylane® Lyft Lidocaine in the Treatment of Moderate to Severe Nasolabial Folds.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The Mean change of the Wrinkle Severity Rating Scale scored by the blinded evaluator.
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of PavéDerm J-fill soft dermal filler vs. Restylane® Lyft lidocaine in the treatment of moderate to severe nasolabial folds.
Detailed Description
This is a single-center, subject and evaluator blinded, intra-individual, split-face controlled clinical trial. After subjects voluntarily give written consent to the participation in the study, his/her eligibility for the study will be judged through demographic and past & medication history investigation and laboratory test.
Subjects eligible in the screening will be enrolled. Each patient will receive PavéDerm J-Fill Soft Dermal Filler in one nasolabial fold and Restylane Lyft Lidocaine (20 mg/mL Hyaluronic acid with 3 mg/ml Lidocaine hydrochloride) in the other by randomization.
The faces of all subjects are going to be digitally photographed at rest upon every visit. The identical ambient conditions will be used for all photographs and assessments. To ensure blinding status, the subjects will be put on eye mask during injection. On injection day, subjects will receive injections, with at least 60 minute apart, to each nasolabial fold by the treating investigator. The amount of injection will be determined according to the width, length, and depth of the nasolabial folds to ensure optimal correction for each subject. The injected volume will not exceed 1.0 mL in ipsilateral nasolabial fold. The relevant information associated with the injection of the investigational medical device will be documented.
After each injection, the treating investigator will observe subjects through 30 minutes for assessment of adverse events. Subjects will be asked about adverse events at each follow-up visit, and any adverse events will be documented for safety assessment.
Clinical efficacy will be assessed by the appropriately trained evaluator using the WSRS and GAIS under blinded fashion, as well as by subjects using GAIS. Pre-treatment photographs of each subject taken at the pre-treatment (baseline) will be reviewed and will be used for comparison. The blinded evaluator will assess the photographs taken at each visit after the study device administration (photographic assessment). All subjects will perform the self-assessment by comparing their appearance in a mirror against a high-magnification photograph taken at baseline at each visit after the study device administration. The mirror symmetry will be reminded in all subjects. Under the explanation by the treating investigator or designee, subjects will assess the satisfaction of wrinkle improvement using the GAIS scoring.
Pain is going to be assessed using a patient self-assessment 10-cm visual analogue scale with anchors at 0 m (no pain) and 10 cm (extreme pain).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men and women aged between 20 and
- •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:
- •Treatment procedure (e.g., bioresorbable fillers, laser/light therapies, botulinum toxin A injections, face lift, facial peels, excisional facial surgery, dermal photorejuvenation clinically significant oral or maxillofacial surgery, etc.) that may interfere with the treatment area or evaluation within 6 months prior to screening as determined by the Principal Investigator.
- •Prescription strength topical retinoids or other topical anti-wrinkle or acne therapies that may interfere with the treatment area or evaluation within 2 weeks prior to screeningas determined by the Principal Investigator.
- •Any oral other anti-wrinkle or acne therapies that may interfere with the treatment area or evaluation within 4 weeks prior to screening as determined by the Principal Investigator.
- •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:
- •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:
Outcomes
Primary Outcomes
The Mean change of the Wrinkle Severity Rating Scale scored by the blinded evaluator.
Time Frame: From baseline to Week 24.
Mean change of the Wrinkle Severity Rating Scale (WSRS) from baseline to Week 24 will be assessed by a blinded evaluator who will judge the severity score from taken photos based on the definition of WSRS Grades.
Secondary Outcomes
- The Mean change of the Wrinkle Severity Rating Scale assessed by the blinded evaluator.(From baseline to Week 4 and 12.)
- Injection pain evaluated by the subjects after injection(0, and 15, 30, 45, and 60 minutes after the injection.)
- The Global Aesthetic Improvement Scale assessed by the blinded evaluator and subjects(At Week 4, 12, and 24)