Safety and Effectiveness of STYLAGE® L for Correction of Moderate and Severe Nasolabial Folds in Chinese Adults

A Controlled, Prospective, Randomized, Multi-Center, Subject and Evaluator-Blinded Study of the Safety and Effectiveness of STYLAGE® L Versus Restylane® for Correction of Moderate and Severe Nasolabial Folds in Chinese Adults

This is a safety and efficacy study of STYLAGE® Lin Chinese adults with Nasolabial Folds.

Study Overview

• Status: Completed
• Conditions: Aging; Skin Wrinkling
• Intervention / Treatment: Device: STYLAGE® L; Device: Active Comparator

Detailed Description

This is a prospective, multi-center, parallel-group, subject and evaluator-blinded, randomized controlled trial to demonstrate the non-inferiority of the study device, STYLAGE® L, when compared to an active comparator for the correction of moderate and severe NLFs.

Subjects will randomly receive STYLAGE® L or the active comparator (ratio 1:1) injection in the NLFs at first visit on Day 0.

Proportion of subjects having a NLFs severity improvement (blinded evaluation), 6 months after treatment initiation will be assessed and compared between the two groups. This will also be done during the other visits (1, 3, 9 and 12 months after treatment initiation). Global aesthetic improvement according to blinded independent evaluator and subject, subjects' satisfaction, and safety parameters will also be assessed during the study period.

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Dong Cheng District
    • Beijing, Dong Cheng District, China, 100730
      • Beijing Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510317
      • Guangdong Second Provincial General Hospital
    • Guangzhou, Guangdong, China, 510289
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Haidian District
    • Beijing, Haidian District, China, 100142
      • Air Force Medical Center, PLA
    • Beijing, Haidian District, China, 100191
      • Peking University Third Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital Sichuan University
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Stomatology Sichuan University
  • Xicheng District
    • Beijing, Xicheng District, China, 100034
      • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Men and women aged ≥ 18 years.
2. Chinese ethnicity.
3. Subjects who wanting to correct his/her nasolabial folds
4. Subjects with moderate to severe nasolabial folds (attaining grade 3 on both side or 4 on both side) in the WSRS of nasolabial fold, per assessment of the Blinded Evaluator.
5. Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period.
6. Subjects with realistic expectations who can understand and comply with the instructions and all visit schedule.
7. Women of childbearing potential (WOCBP) who agree contraception during the study period.
8. Subjects who voluntarily decided the participation of the study and signed the informed consent.
9. Being able to stand mild pain.

Exclusion Criteria:

1. Subjects who are contraindicated to augmentation with HA fillers
2. Subjects who had a history of keloid formation or hypertrophic scar
3. Subjects presenting a scar or skin disorder (i.e. active dermal disease [facial psoriasis, eczema, rosacea, perioral dermatitis, acne, herpes, etc], inflammation or an unhealed wound) below the level of the lower orbital rim that may confound the study evaluation
4. Has ever received semi-permanent fillers or permanent facial implants (eg, calcium hydroxyapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere below the inferior orbital rim, or is planning to be implanted with any of these products at any time during the study
5. Has undergone temporary dermal filler treatment (e.g., hyaluronic acid or collagen) below the inferior orbital rim within 12 months before enrollment or is planning to undergo such treatment during the study
6. Has undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic facial procedures (eg, facial liposuction, aesthetic surgery, face-lift, photomodulation, intense pulsed light, radio frequency, dermabrasion, laser or chemical peel, or other ablative procedures) below the inferior orbital rim within 6 months before enrollment or is planning to undergo any such treatment during the study
7. Subjects who has any history of severe multiple allergies or an allergy resulting in anaphylaxis, or an allergy to hyaluronic acid and/or one of the ingredients of the study products
8. Subject is pregnant or planning to be pregnant during the study period or lactating. Women of childbearing potential who have a positive pregnancy test result during screening. Women of childbearing potential who are unwilling to use effective birth control measures during the full course of the study
9. Subject suffering from a serious or progressive disease, which, in the Investigator's judgment, put the subject at undue risk for participation in this clinical trial (i.e. cancer or pre-cancer, immunocompromised, uncontrolled diabetes, epilepsy, severe cardio-cerebrovascular disease(s) (i.e. stroke, idiopathic aortic stenosis, aneurysm, hypertrophic obstructive cardiomyopathy, ischaemic heart disease, tachyarrhythmias, severe heart failure [classified as NYHA III-IV], etc), , etc.)
10. Subject having a history of cancer within 5 years
11. Subjects who received oral surgery (eg. tooth extraction, orthodontia or implantation) within 6 weeks before enrollment or is planning to undergo any of these procedures during the study
12. Subject has history or active autoimmune disease (e.g. inflammatory bowel disease), active or history of connective tissue disease (rheumatoid arthritis, scleroderma, and systemic lupus erythematosus)
13. Subjects with current or a history of hemorrhagic diseases
14. Subject who received chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic corticosteroids within 3 months (inhaled corticoids are allowed).
15. Subjects unlikely to achieve a meaningful aesthetic result with the prescribed dosage regimen of the study product per Investigator's judgement
16. Subjects who participated in other clinical trial within 30 days or who is in an exclusion period of one.
17. Subjects with uncontrolled hypertension (systolic blood pressure above 160mmHg or diastolic blood pressure above 100 mmHg at resting status), and/or significant liver (serum ALT or AST ≥2X the upper limit of the reference range), kidney (BUN, Urea or Cr≥1.5X the upper limit of the reference range), and/or blood coagulation (PT, or APTT, or INR> 20% of the reference range) disorders per judgement of the Investigator.
18. Current or a history of alcoholism, drug abuse, or drug dependence.
19. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship
20. Subject with a past history of streptococcal disease (manifested by recurrent sore throat or acute rheumatic fever) or with an active infection to streptococcus
21. Has facial hair (e.g., beards, sideburns, etc.), piercing or tattoo in the area to be treated that would interfere with investigation assessments and create inconsistency in required investigation photography during the study period
22. Personnel of the study department, close relatives of the study department personnel (i.e. parents, children, siblings, or spouse), employees, or close relatives of employees at the Sponsor or CRO company.
23. Other conditions the Investigator considers inappropriate for enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group Stylage L ®; Each subject will receive STYLAGE® L in both NLFs. STYLAGE® L will be injected in the NLFs by the Treating Investigator with optional touch-up injections on Month 1.	Device: STYLAGE® L; Injection in both NLFs
Active Comparator: Control group Active Comparator; Each subject will receive the Active Comparator in both NLFs. Active Comparator will be injected in the NLFs by the Treating Investigator with optional touch-up injections on Month 1.	Device: Active Comparator; Injection in both NLFs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WSRS improvement	Percentage of responders, defined by at least 1-point improvement from baseline 5-point WSRS, as measured by the Blinded Evaluator at 6 months after last treatment for both groups.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WSRS improvement	Percentage of responders, defined by at least 1-point improvement from baseline 5-point WSRS, as measured by the Blinded Evaluator	1, 3, 9, and 12 months
GAIS assessment	Percentage of responders, defined by having "Improved", "Much improved" or "Very much improved" according to the Global Aesthetic Improvement Scale (GAIS), as assessed by the subject and the Treating Investigator	1, 3, 9, and 12 months
Subject satisfaction assessment	Percentage of satisfied subjects on each question of the subject satisfaction assessment	1, 3, 6, 9, and 12 month
Device performance	Results of device performance evaluation after the initial and touch-up injection, respectively, by the Treating Investigator for both groups.	initial and touch up
Report of Adverse Event	Product safety will be assessed by collection of local tolerability after each injection session, and Adverse Events (AEs) throughout the study.	Day 0, Month 1, Month 3, Month 6, Month 9, Month 12

Collaborators and Investigators

• Sponsor: Laboratoires Vivacy
• Investigators: Principal Investigator: Yan Wu, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: hyaluronic acid; Dermal filler; Nasolabial Folds
• Other Study ID Numbers: VIV-STYL-L-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No