A Phase 4 interventional study of Juvéderm® VOLIFT™ with Lidocaine in Lip Augmentation, sponsored by Allergan. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Allergan · Phase 4, Interventional, and Other
This is an open-label, multi-center, study where eligible participants will undergo treatment with Juvéderm® VOLIFT™ with Lidocaine injected into the lips for lip augmentation.
This is a prospective, open-label, multi-center, interventional, medical device, post-marketing study. Each participant will act as his/her own control. Eligible participants will undergo treatment with Juvéderm® VOLIFT™ with Lidocaine injected into the lips for lip augmentation.
Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Device: Juvéderm® VOLIFT™ with Lidocaine
Injectable gel that is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant (dermal filler).
Percentage of Participants With a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) Compared to Baseline Assessment at Day 30
The LFS2 is an Investigator assessment of overall lip fullness measured by a 5-point scale where: 0=Minimal (Flat or nearly flat contour; minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). The percentage of participants with a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) compared to Baseline are reported.
Time frame: Baseline (Prior to Treatment) to Day 30
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS)
The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint.
Time frame: Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12
Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire
The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their lips. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Time frame: Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS)
The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported.
Time frame: Day 30, Months 3, 6, and 12
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS
The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported.
Time frame: Day 30, Months 3, 6, and 12
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale
The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported.
Time frame: Day 30, Months 3, 6, and 12
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale
The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported.
Time frame: Day 30, Months 3, 6, and 12
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale
The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported.
Time frame: Day 30, Months 3, 6, and 12
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories
The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported.
Time frame: Day 30, Months 3, 6, and 12
| Milestone | Juvéderm® VOLIFT™ With Lidocaine |
|---|---|
| Started | 60 |
| Completed | 36 |
| Not completed | 24 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Reason not specified | 16 |
The LFS2 is an Investigator assessment of overall lip fullness measured by a 5-point scale where: 0=Minimal (Flat or nearly flat contour; minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). The percentage of participants with a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) compared to Baseline are reported.
| percentage of participants | Juvéderm® VOLIFT™ With Lidocaine |
|---|---|
| Percentage of Participants With a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) Compared to Baseline Assessment at Day 30 | 93.2 |
The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint.
| Participants | Juvéderm® VOLIFT™ With Lidocaine |
|---|---|
| Change from Baseline to Day 30 — -3 Point Change | 0 |
| Change from Baseline to Day 30 — -2 Point Change | 5 |
| Change from Baseline to Day 30 — -1 Point Change | 29 |
| Change from Baseline to Day 30 — 0 Point Change (No change) | 25 |
| Change from Baseline to Day 30 — 1 Point Change | 0 |
| Change from Baseline to Day 30 — 2 Point Change | 0 |
| Change from Baseline to Day 30 — 3 Point Change | 0 |
| Change from Baseline to Month 3 — -3 Point Change | 0 |
| Change from Baseline to Month 3 — -2 Point Change | 4 |
| Change from Baseline to Month 3 — -1 Point Change | 27 |
| Change from Baseline to Month 3 — 0 Point Change (No change) | 21 |
| Change from Baseline to Month 3 — 1 Point Change | 0 |
| Change from Baseline to Month 3 — 2 Point Change | 0 |
| Change from Baseline to Month 3 — 3 Point Change | 0 |
| Change from Baseline to Month 6 — -3 Point Change | 1 |
| Change from Baseline to Month 6 — -2 Point Change | 3 |
| Change from Baseline to Month 6 — -1 Point Change | 22 |
| Change from Baseline to Month 6 — 0 Point Change (No change) | 21 |
| Change from Baseline to Month 6 — 1 Point Change | 4 |
| Change from Baseline to Month 6 — 2 Point Change | 0 |
| Change from Baseline to Month 6 — 3 Point Change | 0 |
| Change from Baseline to Month 12 — -3 Point Change | 0 |
| Change from Baseline to Month 12 — -2 Point Change | 3 |
| Change from Baseline to Month 12 — -1 Point Change | 9 |
| Change from Baseline to Month 12 — 0 Point Change (No change) | 22 |
| Change from Baseline to Month 12 — 1 Point Change | 2 |
| Change from Baseline to Month 12 — 2 Point Change | 0 |
| Change from Baseline to Month 12 — 3 Point Change | 0 |
The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their lips. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
| score on a scale | Juvéderm® VOLIFT™ With Lidocaine |
|---|---|
| Change from Baseline to Day 30 | 45.2 ± 27.16 |
| Change from Baseline to Month 3 | 42.7 ± 30.23 |
| Change from Baseline to Month 6 | 38.5 ± 26.25 |
| Change from Baseline to Month 12 | 23.6 ± 31.78 |
The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported.
| Participants | Juvéderm® VOLIFT™ With Lidocaine |
|---|---|
| Day 30 — 2=Much Improved | 32 |
| Day 30 — 1=Improved | 27 |
| Day 30 — 0=No Change | 0 |
| Day 30 — -1=Worse | 0 |
| Day 30 — -2=Much Worse | 0 |
| Month 3 — 2=Much Improved | 24 |
| Month 3 — 1=Improved | 28 |
| Month 3 — 0=No Change | 0 |
| Month 3 — -1=Worse | 0 |
| Month 3 — -2=Much Worse | 0 |
| Month 6 — 2=Much Improved | 12 |
| Month 6 — 1=Improved | 39 |
| Month 6 — 0=No Change | 0 |
| Month 6 — -1=Worse | 0 |
| Month 6 — -2=Much Worse | 0 |
| Month 12 — 2=Much Improved | 2 |
| Month 12 — 1=Improved | 28 |
| Month 12 — 0=No Change | 6 |
| Month 12 — -1=Worse | 0 |
| Month 12 — -2=Much Worse | 0 |
The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported.
| Participants | Juvéderm® VOLIFT™ With Lidocaine |
|---|---|
| Day 30 — 2=Much Improved | 32 |
| Day 30 — 1=Improved | 25 |
| Day 30 — 0=No Change | 1 |
| Day 30 — -1=Worse | 1 |
| Day 30 — -2=Much Worse | 0 |
| Month 3 — 2=Much Improved | 28 |
| Month 3 — 1=Improved | 21 |
| Month 3 — 0=No Change | 3 |
| Month 3 — -1=Worse | 0 |
| Month 3 — -2=Much Worse | 0 |
| Month 6 — 2=Much Improved | 15 |
| Month 6 — 1=Improved | 34 |
| Month 6 — 0=No Change | 2 |
| Month 6 — -1=Worse | 0 |
| Month 6 — -2=Much Worse | 0 |
| Month 12 — 2=Much Improved | 6 |
| Month 12 — 1=Improved | 25 |
| Month 12 — 0=No Change | 5 |
| Month 12 — -1=Worse | 0 |
| Month 12 — -2=Much Worse | 0 |
The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported.
| Participants | Juvéderm® VOLIFT™ With Lidocaine |
|---|---|
| Day 30 — 0=Not at all | 0 |
| Day 30 — 1 | 0 |
| Day 30 — 2=Somewhat | 3 |
| Day 30 — 3 | 18 |
| Day 30 — 4=Very much | 38 |
| Day 30 — Missing | 0 |
| Month 3 — 0=Not at all | 0 |
| Month 3 — 1 | 0 |
| Month 3 — 2=Somewhat | 0 |
| Month 3 — 3 | 15 |
| Month 3 — 4=Very much | 37 |
| Month 3 — Missing | 0 |
| Month 6 — 0=Not at all | 0 |
| Month 6 — 1 | 0 |
| Month 6 — 2=Somewhat | 1 |
| Month 6 — 3 | 20 |
| Month 6 — 4=Very much | 30 |
| Month 6 — Missing | 0 |
| Month 12 — 0=Not at all | 0 |
| Month 12 — 1 | 0 |
| Month 12 — 2=Somewhat | 4 |
| Month 12 — 3 | 5 |
| Month 12 — 4=Very much | 26 |
| Month 12 — Missing | 1 |
The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported.
| Participants | Juvéderm® VOLIFT™ With Lidocaine |
|---|---|
| Day 30 — 0=Not at all | 1 |
| Day 30 — 1 | 0 |
| Day 30 — 2=Somewhat | 5 |
| Day 30 — 3 | 21 |
| Day 30 — 4=Very much | 32 |
| Month 3 — 0=Not at all | 0 |
| Month 3 — 1 | 0 |
| Month 3 — 2=Somewhat | 1 |
| Month 3 — 3 | 17 |
| Month 3 — 4=Very much | 34 |
| Month 6 — 0=Not at all | 0 |
| Month 6 — 1 | 0 |
| Month 6 — 2=Somewhat | 2 |
| Month 6 — 3 | 21 |
| Month 6 — 4=Very much | 28 |
| Month 12 — 0=Not at all | 0 |
| Month 12 — 1 | 0 |
| Month 12 — 2=Somewhat | 4 |
| Month 12 — 3 | 4 |
| Month 12 — 4=Very much | 28 |
The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported.
| Participants | Juvéderm® VOLIFT™ With Lidocaine |
|---|---|
| Day 30 — 0=Lumpy/Grainy | 0 |
| Day 30 — 1=Faintly Smooth | 1 |
| Day 30 — 2=Somewhat Smooth | 1 |
| Day 30 — 3=Smooth | 22 |
| Day 30 — 4=Very Smooth | 35 |
| Month 3 — 0=Lumpy/Grainy | 0 |
| Month 3 — 1=Faintly Smooth | 0 |
| Month 3 — 2=Somewhat Smooth | 3 |
| Month 3 — 3=Smooth | 14 |
| Month 3 — 4=Very Smooth | 35 |
| Month 6 — 0=Lumpy/Grainy | 0 |
| Month 6 — 1=Faintly Smooth | 0 |
| Month 6 — 2=Somewhat Smooth | 1 |
| Month 6 — 3=Smooth | 17 |
| Month 6 — 4=Very Smooth | 33 |
| Month 12 — 0=Lumpy/Grainy | 0 |
| Month 12 — 1=Faintly Smooth | 1 |
| Month 12 — 2=Somewhat Smooth | 2 |
| Month 12 — 3=Smooth | 0 |
| Month 12 — 4=Very Smooth | 33 |
The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported.
| Participants | Juvéderm® VOLIFT™ With Lidocaine |
|---|---|
| Day 30 — 0=Worse | 0 |
| Day 30 — 1=No Change | 2 |
| Day 30 — 2=Improved | 30 |
| Day 30 — 3=Much Improved | 27 |
| Month 3 — 0=Worse | 0 |
| Month 3 — 1=No Change | 2 |
| Month 3 — 2=Improved | 28 |
| Month 3 — 3=Much Improved | 22 |
| Month 6 — 0=Worse | 0 |
| Month 6 — 1=No Change | 6 |
| Month 6 — 2=Improved | 26 |
| Month 6 — 3=Much Improved | 19 |
| Month 12 — 0=Worse | 0 |
| Month 12 — 1=No Change | 10 |
| Month 12 — 2=Improved | 20 |
| Month 12 — 3=Much Improved | 6 |
Collected over First dose of study treatment to the end of the study (Up to Month 12). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Juvéderm® VOLIFT™ With Lidocaine | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
Safety Analysis Set included all participants who were consented and enrolled into this study and were treated with the investigational product Juvéderm® VOLIFT™ with Lidocaine.
| Age, Continuous(years) | Juvéderm® VOLIFT™ With Lidocaine |
|---|---|
| Mean | 36.8 ± 9.25 |
| Sex: Female, Male(Participants) | Juvéderm® VOLIFT™ With Lidocaine |
|---|---|
| Female | 59 |
| Male | 1 |
| Race and Ethnicity Not Collected(Participants) | Juvéderm® VOLIFT™ With Lidocaine |
|---|
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