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OpenTrials
Completed

NCT Number: NCT05106751

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

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

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Key information

Conditions

Correction of Nasolabial Folds

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

LG Chem investigational site 01

Darmstadt, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic acid dermal filler

Device

Hyaluronic acid dermal filler used for facial volume or wrinkle correction

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Nov 4, 2021
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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