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

Allergan

Status: Completed

Conditions: Nasolabial Fold

Treatments: Device: Restylane®; Device: JUVÉDERM® VOLIFT® with Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02558283

VOLIFT-002

Details and patient eligibility

About

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

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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175 participants in 4 patient groups

JUVÉDERM® VOLIFT® with Lidocaine - Right Side

Experimental group

Description:

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.

Treatment:

Device: JUVÉDERM® VOLIFT® with Lidocaine

Restylane® - Right Side

Active Comparator group

Description:

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

Treatment:

Device: Restylane®

JUVÉDERM® VOLIFT® with Lidocaine - Left Side

Experimental group

Description:

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.

Treatment:

Device: JUVÉDERM® VOLIFT® with Lidocaine

Restylane® - Left Side

Active Comparator group

Description:

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

Treatment:

Device: Restylane®