CompletedNot Applicable

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

China390 participantsStarted 2021-05-06

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

WSRS improvement

Timeframe: Month 6

Trial details

NCT IDNCT04861766

SponsorLaboratoires Vivacy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-16

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