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

LG Chem104 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

104

Conditions

Correction of Nasolabial Folds

Interventions

Hyaluronic acid dermal fillerDEVICE

Hyaluronic acid dermal filler used for facial volume or wrinkle correction

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

LG Chem investigational site 01

Darmstadt, Germany

Outcomes

Primary Outcomes

Mean change on the Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24.

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).

Time frame: 24 weeks from baseline

Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24.

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.

Time frame: 24 weeks from baseline

Data from ClinicalTrials.gov

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