A Safety and Efficacy Study of JUVÉDERM® VOLIFT® With Lidocaine and Restylane® for Nasolabial Folds in Chinese Adults

NCT ID: NCT02558283

Last Updated: 2017-08-30

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

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-25

Study Completion Date

2017-06-19

Brief Summary

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This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in Chinese adults with nasolabial folds.

Detailed Description

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Conditions

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Nasolabial Fold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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JUVÉDERM® VOLIFT® with Lidocaine - Right Side

JUVÉDERM® VOLIFT® with lidocaine injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1.

Group Type EXPERIMENTAL

JUVÉDERM® VOLIFT® with Lidocaine

Intervention Type DEVICE

JUVÉDERM® VOLIFT® with lidocaine injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.

Restylane® - Right Side

Restylane® injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1.

Group Type ACTIVE_COMPARATOR

Restylane®

Intervention Type DEVICE

Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.

JUVÉDERM® VOLIFT® with Lidocaine - Left Side

JUVÉDERM® VOLIFT® with lidocaine injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1.

Group Type EXPERIMENTAL

JUVÉDERM® VOLIFT® with Lidocaine

Intervention Type DEVICE

JUVÉDERM® VOLIFT® with lidocaine injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.

Restylane® - Left Side

Restylane® injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1.

Group Type ACTIVE_COMPARATOR

Restylane®

Intervention Type DEVICE

Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.

Interventions

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JUVÉDERM® VOLIFT® with Lidocaine

JUVÉDERM® VOLIFT® with lidocaine injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.

Intervention Type DEVICE

Restylane®

Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Presence of nasolabial folds
* Agree to refrain from treatment with other anti-wrinkle/volumizers below the eye for the duration of the study

Exclusion Criteria

* Ever received semi-permanent fillers or permanent facial implants below the eyes, or plans to receive these treatments during the study
* Undergone temporary dermal filler treatment (eg, hyaluronic acid or collagen) below the eyes within 12 months, or plans to undergo these treatments during the study
* Undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic facial procedures in the face or neck within 6 months, or plans to undergo these treatments during the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi Jia

Role: STUDY_DIRECTOR

Allergan

Locations

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China Japan Friendship Hospital

Beijing, , China

Site Status

Peking University Third Hospital

Beijing, , China

Site Status

General Hospital of Guangzhou Military Command of PLA

Guangzhou, , China

Site Status

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Guangzhou, , China

Site Status

Shanghai 9th Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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VOLIFT-002

Identifier Type: -

Identifier Source: org_study_id

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