A Safety and Effectiveness Study of JUVÉDERM VOLIFT® XC Versus Control for Moderate to Severe Nasolabial Folds

Allergan

Status: Completed

Conditions: Moderate to Severe Nasolabial Folds

Treatments: Device: JUVEDERM VOLIFT® XC; Device: Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT01976663

S17L-001

Details and patient eligibility

About

A prospective, multicenter, within-subject controlled study of the safety and effectiveness of JUVÉDERM VOLIFT® XC versus Control for the correction of moderate to severe nasolabial folds (NLFs).

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 2 visible moderate to severe nasolabial folds
• Agree to refrain from undergoing other anti-wrinkle/volumizing treatments in the lower two-thirds of the face for the duration of the study

Exclusion criteria

• Undergone facial tissue augmentation with dermal fillers in the lower two-thirds of the face within the past 12 months
• Undergone facial tissue augmentation with fat injections, botulinum toxin injections in the lower two-thirds of the face, mesotherapy, or cosmetic facial procedures in the face or neck within the past 6 months
• Received semi-permanent fillers or permanent facial implants anywhere in the lower face

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups

VOLIFT® XC NLFs

Experimental group

Description:

Nasolabial folds treated with JUVEDERM VOLIFT® XC.

Treatment:

Device: JUVEDERM VOLIFT® XC

Control NLFs

Active Comparator group

Description:

Nasolabial folds treated with Control.

Treatment:

Device: Control