Moderate to Severe Nasolabial Folds
Conditions
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).
Interventions
DEVICEJUVEDERM 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.
DEVICEControl
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.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
126 subjects were enrolled (Enrolled Population); 123 subjects were randomized and treated (Modified Intent-to-Treat). Each subject had one nasolabial fold treated with JUVEDERM VOLIFT® XC and one treated with control. After initial treatment, subjects were eligible for touch-up, asymmetry correction, and repeat treatment per protocol.
Participants by arm
| Arm | Count |
|---|---|
| JUVEDERM VOLIFT® XC Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side. | 123 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Completed 18 mos but no repeat treatment | 24 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Personal Reasons | 6 |
| Overall Study | Screen Failure | 3 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | JUVEDERM VOLIFT® XC |
|---|---|
| Age, Customized 30 to 50 years | 36 Participants |
| Age, Customized 51 to 65 years | 72 Participants |
| Age, Customized >65 years | 15 Participants |
| Sex: Female, Male Female | 117 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 123 | 27 / 123 | 0 / 123 | 19 / 93 |
| serious Total, serious adverse events | 0 / 123 | 0 / 123 | 5 / 123 | 0 / 93 |
Outcome results
Primary
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.
Time frame: Baseline, Month 6
Population: modified intent-to-treat (mITT): all randomized and treated subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVEDERM VOLIFT® XC | Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS) | Baseline | 2.6 Scores on a Scale | Standard Deviation 0.49 |
| JUVEDERM VOLIFT® XC | Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS) | Month 6 (N=117, 117) | 1.4 Scores on a Scale | Standard Deviation 0.67 |
| Control | Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS) | Baseline | 2.6 Scores on a Scale | Standard Deviation 0.49 |
| Control | Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS) | Month 6 (N=117, 117) | 1.3 Scores on a Scale | Standard Deviation 0.72 |
Primary
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.
Time frame: Baseline, Month 6
Population: modified intent-to-treat (mITT): all randomized and treated subjects with data for this outcome measure
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| JUVEDERM VOLIFT® XC | Percentage of Nasolabial Folds With ≥1-Point Improvement | 93.2 Percentage of Nasolabial Folds | 95% Confidence Interval 0.49 |
| Control | Percentage of Nasolabial Folds With ≥1-Point Improvement | 86.3 Percentage of Nasolabial Folds | — |
Secondary
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.
Time frame: Baseline, Month 12
Population: modified intent-to-treat (mITT): all randomized and treated subjects with data at this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVEDERM VOLIFT® XC | Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score | Baseline | 32.1 Scores on a Scale | Standard Deviation 14.7 |
| JUVEDERM VOLIFT® XC | Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score | Month 12 (N=112, 111) | 25.8 Scores on a Scale | Standard Deviation 23.08 |
| Control | Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score | Baseline | 32.0 Scores on a Scale | Standard Deviation 14.94 |
| Control | Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score | Month 12 (N=112, 111) | 23.4 Scores on a Scale | Standard Deviation 22.83 |
Secondary
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.
Time frame: Baseline, Month 12
Population: modified intent-to-treat (mITT): all randomized and treated subjects with data for this outcome measure
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| JUVEDERM VOLIFT® XC | Percentage of Nasolabial Folds With ≥1-Point Improvement | 57.5 Percentage of Nasolabial Folds | 95% Confidence Interval 0.49 |
| Control | Percentage of Nasolabial Folds With ≥1-Point Improvement | 56.6 Percentage of Nasolabial Folds | — |