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

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

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).

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Nasolabial Folds
• Intervention / Treatment: Device: JUVEDERM VOLIFT® XC; Device: Control

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center P.C.
  • California
    • Los Angeles, California, United States, 90036
      • Vitiligo and Pigmentation Institute of Southern California
    • San Francisco, California, United States, 94115
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Skin Research Institute
    • Coral Gables, Florida, United States, 33146
      • Dermatology Research Institute, LLC
    • West Palm Beach, Florida, United States, 33401
  • Illinois
    • Chicago, Illinois, United States, 60611

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VOLIFT® XC NLFs; Nasolabial folds treated with JUVEDERM VOLIFT® XC.	Device: 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.
Active Comparator: Control NLFs; Nasolabial folds treated with Control.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)	Nasolabial fold severity is assessed by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). Mean change from baseline in NFLSS is defined as score at baseline minus score at Month 6. A negative number change from baseline indicated improvement and a positive number change from baseline indicated worsening.	Baseline, Month 6
Percentage of Nasolabial Folds With ≥1-Point Improvement	Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported.	Baseline, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Nasolabial Folds With ≥1-Point Improvement	Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported.	Baseline, Month 12
Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score	Subjects evaluate nasolabial folds on the 5-item Nasolabial Folds module of the FACE-Q questionnaire. Responses to the 5 items are combined to create a scale score that ranged from 0 to 100, where 0 indicates that the subject is extremely bothered and 100 indicates that the subject is not all bothered by the appearance of the nasolabial fold. Change from baseline is defined as the score at Month 12 minus the baseline score. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.	Baseline, Month 12

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Monheit G, Beer K, Hardas B, Grimes PE, Weichman BM, Lin V, Murphy DK. Safety and Effectiveness of the Hyaluronic Acid Dermal Filler VYC-17.5L for Nasolabial Folds: Results of a Randomized, Controlled Study. Dermatol Surg. 2018 May;44(5):670-678. doi: 10.1097/DSS.0000000000001529.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2013
• Primary Completion (Actual): March 17, 2015
• Study Completion (Actual): October 26, 2015

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: October 30, 2013
• First Posted (Estimate): November 6, 2013

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: S17L-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes