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

October 31, 2023 updated by: LG Chem
A Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Darmstadt, Germany
        • LG Chem investigational site 01

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YVOIRE Classic plus
Device: Hyaluronic acid dermal filler
Hyaluronic acid dermal filler used for facial volume or wrinkle correction
Active Comparator: Restylane Lidocaine
Device: Hyaluronic acid dermal filler
Hyaluronic acid dermal filler used for facial volume or wrinkle correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change on the Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24.
Time Frame: 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).
24 weeks from baseline
Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24.
Time Frame: 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.
24 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2021

Primary Completion (Actual)

September 19, 2022

Study Completion (Actual)

April 3, 2023

Study Registration Dates

First Submitted

October 24, 2021

First Submitted That Met QC Criteria

October 24, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-HACL033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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