A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds

Phase 4

Completed

• Conditions: Correction of Nasolabial Folds
• Interventions: Device: Hyaluronic acid dermal filler

• Registration Number: NCT05106751
• Lead Sponsor: LG Chem

Brief Summary

A Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF.

Detailed Description

This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Classic plus Versus Comparator for Temporary Correction of Nasolabial Folds.

Study Timeline

• Study Start: 2021-10-21
• Study First Submitted: 2021-10-24
• Study First Submitted QC: 2021-10-24
• Study First Posted: 2021-11-04
• Primary Completion: 2022-09-19
• Study Completion: 2023-04-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Male or female 21 years or above age.
• 2 or 3 of the 5-point (0-4) NLFRS (Nasolabial Fold Rating Scale).
• Agree to use proper contraception as guided in the protocol.
• Signed for Informed Consent.

Exclusion Criteria

• have received permanent facial implants anywhere in the face or neck or planning during the investigation.
• have undergone facial plastic surgery of the lower face and nasolabial region within 12 weeks
• have undergone semi-permanent filler in lower face
• have undergone temporary dermal filler treatment in the lower two-thirds of face within 12 months
• Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower two-thirds of face
• Have undergone mesotherapy or cosmetic procedures in face or neck within 6 months
• have used any over-the-counter anti-wrinkle products or prescription anti-wrinkle medicines for the nasolabial folds within 28 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YVOIRE Classic plus	Hyaluronic acid dermal filler	-
Restylane Lidocaine	Hyaluronic acid dermal filler	-

Primary Outcome Measures

Name	Time	Method
Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24.	24 weeks from baseline	To evaluate the performance of YVOIRE Classic plus on Nasolabial fold 24 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Nasolabial Fold Rating Scale (NLFRS) from baseline to 24 weeks will be calculated.
Mean change on the Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24.	24 weeks from baseline	To evaluate the performance of YVOIRE Classic plus on Nasolabial Fold 24 weeks after treatment, the mean change from baseline to 24 weeks will be measured using 5-point Nasolabial Fold Rating Scale (NLFRS). NLFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Extreme).

Trial Locations

Locations (1)

LG Chem investigational site 01; 🇩🇪 Darmstadt, Germany