N/A
N=126
A Safety and Effectiveness Study of JUVÉDERM VOLIFT® XC Versus Control for Moderate to Severe Nasolabial Folds
Moderate to Severe Nasolabial Folds
Bottom Line
View on ClinicalTrials.gov: NCT01976663 ↗Enrolled (actual)
126
Serious AEs
1.1%
Results posted
May 2017
Primary outcome: Primary: Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS) — 2.6; 2.6; 1.4; 1.3 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- JUVEDERM VOLIFT® XC (Device); Control (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS) |
2.6; 2.6; 1.4; 1.3 | — |
| PRIMARY Percentage of Nasolabial Folds With ≥1-Point Improvement |
57.5; 56.6 | — |
| SECONDARY Percentage of Nasolabial Folds With ≥1-Point Improvement |
57.5; 56.6 | — |
| SECONDARY Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score |
32.1; 32.0; 25.8; 23.4 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01976663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.