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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-29

Study Completion Date

2015-10-26

Brief Summary

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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).

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Detailed Description

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Conditions

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Moderate to Severe Nasolabial Folds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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VOLIFT® XC NLFs

Nasolabial folds treated with JUVEDERM VOLIFT® XC.

Group Type EXPERIMENTAL

JUVEDERM VOLIFT® XC

Intervention Type DEVICE

Up to 4 mLs JUVEDERM VOLIFT® XC injected intradermally in one NLF (total; including initial and touch-up treatments) and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. For asymmetric correction, only the more severe NLF is eligible for asymmetric correction.

Control NLFs

Nasolabial folds treated with Control.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DEVICE

Up to 4 mLs Control injected intradermally in opposite NLF (total; including initial and touch-up treatments). Up to 4 mLs JUVEDERM VOLIFT XC is allowed for asymmetry correction and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. Only the more severe NLF is eligible for asymmetric correction.

Interventions

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JUVEDERM VOLIFT® XC

Up to 4 mLs JUVEDERM VOLIFT® XC injected intradermally in one NLF (total; including initial and touch-up treatments) and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. For asymmetric correction, only the more severe NLF is eligible for asymmetric correction.

Intervention Type DEVICE

Control

Up to 4 mLs Control injected intradermally in opposite NLF (total; including initial and touch-up treatments). Up to 4 mLs JUVEDERM VOLIFT XC is allowed for asymmetry correction and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. Only the more severe NLF is eligible for asymmetric correction.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No