Effectiveness and Safety of YVOIRE Y-Solution 540

Not Applicable

Completed

• Conditions: Wrinkles in the Nasolabial Folds
• Interventions: Device: YVOIRE Y-Solution 540; Device: YVOIRE volume plus

• Registration Number: NCT04855188
• Lead Sponsor: LG Chem

Brief Summary

To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-22
• Study Start: 2021-07-01
• Primary Completion: 2022-09-29
• Study Completion: 2024-07-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

Inclusion Criteria

• 3 (moderate) or 4 (severe) on the 5-graded WSRS
• who sign the written informed consent form

Exclusion Criteria

• who have received permanent facial implants
• who have received semi-permanent fillers
• who have undergone temporary dermal filler treatment within 12 months
• who have undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic procedures within 6 months
• who have a history of anaphylaxis or allergy to lidocaine, hyaluronic acid (HA) products, or streptococcal protein

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YVOIRE Y-Solution 540	YVOIRE Y-Solution 540	-
YVOIRE volume plus	YVOIRE volume plus	-

Primary Outcome Measures

Name	Time	Method
WSRS responder rate	24 weeks after the last injection	the proportion of subjects with ≥ 1 grade improvement on the wrinkle severity rating scale (WSRS) score

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China