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

NCT05106751 | Completed Phase 4

• 1 other identifier: LG-HACL033
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Correction of Nasolabial Folds

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  24 weeks from baseline

Study Arms (2)

YVOIRE Classic plus

EXPERIMENTAL

Device: Hyaluronic acid dermal filler

Restylane Lidocaine

ACTIVE COMPARATOR

Device: Hyaluronic acid dermal filler

Interventions

Hyaluronic acid dermal filler DEVICE

Hyaluronic acid dermal filler used for facial volume or wrinkle correction

Restylane Lidocaine; YVOIRE Classic plus

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 21 years or above age.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

LG Chem investigational site 01

Darmstadt, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 4, 2021
• Study Start: October 21, 2021
• Primary Completion: September 19, 2022
• Study Completion: April 3, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)