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

NCT04861766 | Completed

• 1 other identifier: VIV-STYL-L-01
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Aging; Skin Wrinkling

Keywords

hyaluronic acid; Nasolabial Folds; Dermal filler

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• WSRS improvement

  1, 3, 9, and 12 months

• GAIS assessment

  1, 3, 9, and 12 months

• Subject satisfaction assessment

  1, 3, 6, 9, and 12 month

• Device performance

  initial and touch up

• Report of Adverse Event

  Day 0, Month 1, Month 3, Month 6, Month 9, Month 12

Study Arms (2)

Treatment group Stylage L ®

EXPERIMENTAL

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

Control group Active Comparator

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

Interventions

STYLAGE® L DEVICE

Injection in both NLFs

Treatment group Stylage L ®

Active Comparator DEVICE

Injection in both NLFs

Control group Active Comparator

Eligibility Criteria

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

You may qualify if:

• Men and women aged ≥ 18 years.
• Chinese ethnicity.
• Subjects who wanting to correct his/her nasolabial folds
• 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.
• Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period.
• Subjects with realistic expectations who can understand and comply with the instructions and all visit schedule.
• Women of childbearing potential (WOCBP) who agree contraception during the study period.
• Subjects who voluntarily decided the participation of the study and signed the informed consent.
• Being able to stand mild pain.

You may not qualify if:

• Subjects who are contraindicated to augmentation with HA fillers
• Subjects who had a history of keloid formation or hypertrophic scar
• 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
• 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
• 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
• 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
• 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
• 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
• 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.)
• Subject having a history of cancer within 5 years
• 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
• 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)
• Subjects with current or a history of hemorrhagic diseases
• Subject who received chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic corticosteroids within 3 months (inhaled corticoids are allowed).
• Subjects unlikely to achieve a meaningful aesthetic result with the prescribed dosage regimen of the study product per Investigator's judgement

Sponsors & Collaborators

• Laboratoires Vivacy: lead

Study Sites (8)

Beijing Hospital

Beijing, Dong Cheng District, 100730, China

Location

SUN YAT-SEN Memorial Hospital, SUN YAT-SEN University

Guangzhou, Guangdong, 510289, China

Location

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510317, China

Location

Air Force Medical Center, PLA

Beijing, Haidian District, 100142, China

Location

Peking University Third Hospital

Beijing, Haidian District, 100191, China

Location

West China Hospital of Stomatology Sichuan University

Chengdu, Sichuan, 610041, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, 610041, China

Location

Peking University First Hospital

Beijing, Xicheng District, 100034, China

Location

Study Officials

• Yan Wu

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The identity of individual investigation materials will remain unknown to the independent Blinded Evaluator and all subjects.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Controlled, Prospective, Randomized, Multi-Center, Subject and Evaluator-Blinded Study

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 27, 2021
• Study Start: May 6, 2021
• Primary Completion: August 16, 2022
• Study Completion: March 31, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

CN (8)