Evaluate the Efficacy and Safety of Lidocaine-Containing Hyaluronic Acid Filler in the Treatment of Nasolabial Folds.

NCT05040594 | Completed

• 1 other identifier: YSP-REN3010-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Wrinkles Such as Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• The Mean change of the Wrinkle Severity Rating Scale scored by the blinded evaluator.

  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.

  From baseline to Week 24.

Secondary Outcomes (3)

• 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

Study Arms (2)

Treatment A (right) B (left)

EXPERIMENTAL

Subjects will receive PavéDerm J-Fill Soft Dermal Filler and Restylane® Lyft Lidocaine. One product will be randomized, per NLF.

Device: PavéDerm J-Fill Soft Dermal Filler; Device: Restylane® Lyft Lidocaine

Treatment B (right) A (left)

EXPERIMENTAL

Subjects will receive Restylane® Lyft Lidocaine and PavéDerm J-Fill Soft Dermal Filler. One product will be randomized, per NLF.

Device: PavéDerm J-Fill Soft Dermal Filler; Device: Restylane® Lyft Lidocaine

Interventions

PavéDerm J-Fill Soft Dermal Filler DEVICE

Sodium Hyaluronate 20 mg with Lidocaine hydrochloride 3 mg/mL

Treatment A (right) B (left); Treatment B (right) A (left)

Restylane® Lyft Lidocaine DEVICE

Sodium Hyaluronate 20 mg with Lidocaine hydrochloride 3 mg/mL

Treatment A (right) B (left); Treatment B (right) A (left)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Autologous fat, polymethylmethacrylate or other acrylates, polyacrylamide, polyethylene oxide, polylactic acid, permanent expander prosthesis (e.g., soft-form or silicon), or other implant materials.
• Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with the judgment of the treatment effect.
• Subjects with a history of anaphylaxis or history or presence of multiple severe allergies, allergy to lidocaine or other amide-type anesthetics, hyaluronic acid products, or any component of devices.
• The subject is, in the Investigator's opinion, at an undue risk based on the precautions, warnings, and contraindications for local lidocaine anesthetics.
• Subjects with a history of a hypertrophic scar, keloid, or clinically significant skin pigmentation disorders.

Sponsors & Collaborators

• Yung Shin Pharm. Ind. Co., Ltd.: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Study Officials

• Chen Chih-Chiang, Ph.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: September 10, 2021
• Study Start: December 26, 2019
• Primary Completion: October 15, 2020
• Study Completion: November 5, 2020
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

TW (1)