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 Chem

Status and phase

Completed

Phase 4

Conditions

Correction of Nasolabial Folds

Treatments

Device: Hyaluronic acid dermal filler

Study type

Interventional

Funder types

Industry

Identifiers

NCT05106751

LG-HACL033

Details and patient eligibility

About

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

Full 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.

Enrollment

104 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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