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

NCT ID: NCT05106751

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-21

Study Completion Date

2023-04-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Correction of Nasolabial Folds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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YVOIRE Classic plus

Group Type EXPERIMENTAL

Hyaluronic acid dermal filler

Intervention Type DEVICE

Hyaluronic acid dermal filler used for facial volume or wrinkle correction

Restylane Lidocaine

Group Type ACTIVE_COMPARATOR

Hyaluronic acid dermal filler

Intervention Type DEVICE

Hyaluronic acid dermal filler used for facial volume or wrinkle correction

Interventions

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Hyaluronic acid dermal filler

Hyaluronic acid dermal filler used for facial volume or wrinkle correction

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LG Chem

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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LG Chem investigational site 01

Darmstadt, , Germany

Site Status

Countries

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Germany

Other Identifiers

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LG-HACL033

Identifier Type: -

Identifier Source: org_study_id

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