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Effectiveness and Safety of YVOIRE Y-Solution 540

NCT ID: NCT04855188

Last Updated: 2024-12-19

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

NA

Total Enrollment

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-07-14

Brief Summary

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To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection

Detailed Description

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Conditions

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Wrinkles in the 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 Y-Solution 540

Group Type EXPERIMENTAL

YVOIRE Y-Solution 540

Intervention Type DEVICE

Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.

YVOIRE volume plus

Group Type ACTIVE_COMPARATOR

YVOIRE volume plus

Intervention Type DEVICE

Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.

Interventions

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YVOIRE Y-Solution 540

Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.

Intervention Type DEVICE

YVOIRE volume plus

Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 3 (moderate) or 4 (severe) on the 5-graded WSRS
* who sign the written informed consent form

Exclusion Criteria

* who have received permanent facial implants
* who have received semi-permanent fillers
* who have undergone temporary dermal filler treatment within 12 months
* who have undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic procedures within 6 months
* who have a history of anaphylaxis or allergy to lidocaine, hyaluronic acid (HA) products, or streptococcal protein
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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LG-HACL027

Identifier Type: -

Identifier Source: org_study_id