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

August 28, 2017 updated by: Allergan
This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in Chinese adults with nasolabial folds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University Third Hospital
      • Beijing, China
        • China Japan Friendship Hospital
      • Guangzhou, China
        • General Hospital of Guangzhou Military Command of PLA
      • Guangzhou, China
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Shanghai, China
        • Shanghai 9Th Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Active Comparator: 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.
Device: Restylane®
Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.
Experimental: 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.
Device: 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.
Active Comparator: 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.
Device: Restylane®
Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS)
Time Frame: Month 6
Month 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Yi Jia, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2016

Primary Completion (Actual)

June 19, 2017

Study Completion (Actual)

June 19, 2017

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VOLIFT-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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