NCT02558283

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2017

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

September 22, 2015

Last Update Submit

August 28, 2017

Conditions

Nasolabial Fold

Outcome Measures

Primary Outcomes (1)

  • Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS)

    Month 6

Secondary Outcomes (3)

  • 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

Study Arms (4)

JUVÉDERM® VOLIFT® with Lidocaine - Right Side

EXPERIMENTAL

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

Restylane® - Right Side

ACTIVE COMPARATOR

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®

JUVÉDERM® VOLIFT® with Lidocaine - Left Side

EXPERIMENTAL

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

Restylane® - Left Side

ACTIVE COMPARATOR

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®

Interventions

JUVÉDERM® VOLIFT® with LidocaineDEVICE

JUVÉDERM® VOLIFT® with lidocaine 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 SideJUVÉDERM® VOLIFT® with Lidocaine - Right Side
Restylane®DEVICE

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

Restylane® - Left SideRestylane® - Right Side

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

China Japan Friendship Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

General Hospital of Guangzhou Military Command of PLA

Guangzhou, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Guangzhou, China

Location

Shanghai 9th Hospital

Shanghai, China

Location

Study Officials

  • Yi Jia

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 23, 2015

Study Start

January 25, 2016

Primary Completion

June 19, 2017

Study Completion

June 19, 2017

Last Updated

August 30, 2017

Record last verified: 2017-08

Locations

CN(5)