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
1 other identifier
interventional
126
1 country
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2013
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 29, 2013
CompletedFirst Submitted
Initial submission to the registry
October 30, 2013
CompletedFirst Posted
Study publicly available on registry
November 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2015
CompletedResults Posted
Study results publicly available
May 22, 2017
CompletedMay 10, 2019
March 1, 2019
1.4 years
October 30, 2013
April 14, 2017
April 29, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Percentage of Nasolabial Folds With ≥1-Point Improvement
Baseline, Month 12
Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score
Baseline, Month 12
Study Arms (2)
VOLIFT® XC NLFs
EXPERIMENTALNasolabial folds treated with JUVEDERM VOLIFT® XC.
Control NLFs
ACTIVE COMPARATORNasolabial folds treated with Control.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (7)
Total Skin and Beauty Dermatology Center P.C.
Birmingham, Alabama, 35205, United States
Vitiligo and Pigmentation Institute of Southern California
Los Angeles, California, 90036, United States
Unknown Facility
San Francisco, California, 94115, United States
Dermatology Research Institute, LLC
Coral Gables, Florida, 33146, United States
Skin Research Institute
Coral Gables, Florida, 33146, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Related Publications (1)
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.
PMID: 29701621BACKGROUND
Results Point of Contact
- Title
- Allergan Inc.,
- Organization
- Allergan, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2013
First Posted
November 6, 2013
Study Start
October 29, 2013
Primary Completion
March 17, 2015
Study Completion
October 26, 2015
Last Updated
May 10, 2019
Results First Posted
May 22, 2017
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share