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

Not Applicable

Completed

• Conditions: Nasolabial Fold
• Interventions: Device: Restylane®; Device: JUVÉDERM® VOLIFT® with Lidocaine

• Registration Number: NCT02558283
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Study Start: 2016-01-25
• Primary Completion: 2017-06-19
• Study Completion: 2017-06-19
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Restylane® - Right Side	Restylane®	Restylane® injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1.
JUVÉDERM® VOLIFT® with Lidocaine - Right Side	JUVÉDERM® VOLIFT® with Lidocaine	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.
JUVÉDERM® VOLIFT® with Lidocaine - Left Side	JUVÉDERM® VOLIFT® with Lidocaine	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.
Restylane® - Left Side	Restylane®	Restylane® injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1.

Primary Outcome Measures

Name	Time	Method
Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS)	Month 6

Secondary Outcome Measures

Name	Time	Method
Subject's Assessment of Procedural Pain on an 11-Point Scale	Day 1
Investigator's Assessment of Each NLF on the 5-Point Global Aesthetic Improvement Scale (GAIS)	Month 6
Subject's Assessment of Each NLF on the 5-Point GAIS	Month 6

Trial Locations

Locations (5)

Peking University Third Hospital; 🇨🇳 Beijing, China

General Hospital of Guangzhou Military Command of PLA; 🇨🇳 Guangzhou, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Guangzhou, China

Shanghai 9th Hospital; 🇨🇳 Shanghai, China

China Japan Friendship Hospital; 🇨🇳 Beijing, China