Nasolabial Fold
Conditions
Brief summary
This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in Chinese adults with nasolabial folds.
Interventions
JUVÉDERM® VOLIFT® with lidocaine injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.
DEVICERestylane®
Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS) | Month 6 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed