Overview

This trial is active, not recruiting.

Condition nasolabial fold
Treatments juvÉderm® volift® with lidocaine, restylane®
Sponsor Allergan
Start date January 2016
End date December 2017
Trial size 175 participants
Trial identifier NCT02558283, VOLIFT-002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(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.
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® injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1.
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 injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1.
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® injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1.
restylane®
Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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 information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Allergan.