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

Not Applicable

Completed

• Conditions: Moderate to Severe Nasolabial Folds
• Interventions: Device: JUVEDERM VOLIFT® XC; Device: Control

• Registration Number: NCT01976663
• Lead Sponsor: Allergan

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-29
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Primary Completion: 2015-03-17
• Study Completion: 2015-10-26
• Results First Submitted: 2017-04-14
• Results First Submitted QC: 2017-04-14
• Results First Posted: 2017-05-22
• Status Verified: 2019-03
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VOLIFT® XC NLFs	JUVEDERM VOLIFT® XC	Nasolabial folds treated with JUVEDERM VOLIFT® XC.
Control NLFs	Control	Nasolabial folds treated with Control.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)	Baseline, Month 6	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.
Percentage of Nasolabial Folds With ≥1-Point Improvement	Baseline, Month 6	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Nasolabial Folds With ≥1-Point Improvement	Baseline, Month 12	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.
Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score	Baseline, Month 12	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.

Trial Locations

Locations (4)

Total Skin and Beauty Dermatology Center P.C.; 🇺🇸 Birmingham, Alabama, United States

Vitiligo and Pigmentation Institute of Southern California; 🇺🇸 Los Angeles, California, United States

Skin Research Institute; 🇺🇸 Coral Gables, Florida, United States

Dermatology Research Institute, LLC; 🇺🇸 Coral Gables, Florida, United States