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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Juvéderm® VOLIFT™ with Lidocaine | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juvéderm® VOLIFT™ with Lidocaine | Device | Injectable gel that is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant (dermal filler). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Prior to Treatment) to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Milenio | Lisbon | 1600-166 | Portugal | |||
| ClÃnica Secret Beauty |
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| ID | Title | Description |
|---|---|---|
| FG000 | Juvéderm® VOLIFT™ With Lidocaine | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Juvéderm® VOLIFT™ With Lidocaine | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. | Posted | Number | percentage of participants | Baseline (Prior to Treatment) to Day 30 |
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First dose of study treatment to the end of the study (Up to Month 12)
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Juvéderm® VOLIFT™ With Lidocaine | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 10, 2019 | Jun 9, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2019 | Jun 9, 2021 | SAP_001.pdf |
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All participants will sign an informed consent form, and begin at the Screening Visit. Filler treatment (Juvéderm® VOLIFT™ with Lidocaine) will be performed at (Initial Treatment visit) and data will be collected at this visit for all relevant parameters as per the Schedule of Study Procedures, Treatments and Assessments. Fourteen days after the initial treatment, participants will return to the clinic and the Investigator will assess whether a Touch-up treatment is to be performed at this visit. Follow up visits will occur at Day 30 and 3, 6, and 12 months after the last treatment.
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| 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-Qâ„¢ 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 30, Months 3, 6, and 12 |
| Lisbon |
| 1600-503 |
| Portugal |
| Medical and Cosmetic Clinic | Edinburgh | EH3 6RS | United Kingdom |
| MediZen Ltd | Sutton Coldfield | B74 2UG | United Kingdom |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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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). |
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| Secondary | 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. | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with available data for analysis at the given timepoint | Posted | Count of Participants | Participants | Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12 |
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| Secondary | Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire | The FACE-Qâ„¢ 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. | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12 |
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| Secondary | 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. | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Posted | Count of Participants | Participants | Day 30, Months 3, 6, and 12 |
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| Secondary | 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. | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Posted | Count of Participants | Participants | Day 30, Months 3, 6, and 12 |
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| Secondary | 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. | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Posted | Count of Participants | Participants | Day 30, Months 3, 6, and 12 |
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| Secondary | 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. | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Posted | Count of Participants | Participants | Day 30, Months 3, 6, and 12 |
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| Secondary | 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. | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Posted | Count of Participants | Participants | Day 30, Months 3, 6, and 12 |
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| Secondary | 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. | Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Posted | Count of Participants | Participants | Day 30, Months 3, 6, and 12 |
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| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| -1 Point Change |
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| 0 Point Change (No change) |
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| 1 Point Change |
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| 2 Point Change |
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| 3 Point Change |
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| Change from Baseline to Month 3 |
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| Change from Baseline to Month 6 |
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| Change from Baseline to Month 12 |
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| Change from Baseline to Month 6 |
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| Change from Baseline to Month 12 |
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| 0=No Change |
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| -1=Worse |
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| -2=Much Worse |
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| Month 3 |
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| Month 6 |
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| Month 12 |
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| 0=No Change |
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| -1=Worse |
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| -2=Much Worse |
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| Month 3 |
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| Month 6 |
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| Month 12 |
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| 2=Somewhat |
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| 3 |
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| 4=Very much |
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| Missing |
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| Month 3 |
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| Month 6 |
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| Month 12 |
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| 2=Somewhat |
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| 3 |
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| 4=Very much |
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| Month 3 |
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| Month 6 |
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| Month 12 |
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| 2=Somewhat Smooth |
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| 3=Smooth |
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| 4=Very Smooth |
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| Month 3 |
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| Month 6 |
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| Month 12 |
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| 2=Improved |
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| 3=Much Improved |
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| Month 3 |
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| Month 6 |
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| Month 12 |
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