Trial Outcomes & Findings for Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults (NCT NCT03519204)
NCT ID: NCT03519204
Last Updated: 2019-08-06
Results Overview
The investigator assessed the participant's lip fullness using the 5-point LFS 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). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.
COMPLETED
NA
176 participants
Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)
2019-08-06
Participant Flow
Three participants were randomized to the no-treatment control group but were treated in error on the day of randomization and were included in the treatment group for the Modified-intent-to-treat (mITT) population and the Safety population for analysis.
Participant milestones
| Measure |
No-treatment Control
No-treatment was administered during control period. After 3 months, participants were eligible to receive treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment.
|
JUVÉDERM® VOLBELLA® XC With Lidocaine
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
133
|
|
Overall Study
mITT Population
|
33
|
130
|
|
Overall Study
Safety Population
|
40
|
136
|
|
Overall Study
COMPLETED
|
30
|
118
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
Reasons for withdrawal
| Measure |
No-treatment Control
No-treatment was administered during control period. After 3 months, participants were eligible to receive treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment.
|
JUVÉDERM® VOLBELLA® XC With Lidocaine
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
8
|
|
Overall Study
Withdrawal by Subject
|
9
|
7
|
|
Overall Study
Other Miscellaneous Reasons
|
1
|
0
|
Baseline Characteristics
mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
Baseline characteristics by cohort
| Measure |
No-treatment Control
n=33 Participants
No-treatment was administered during control period. After 3 months, participants were eligible to receive treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment.
|
JUVÉDERM® VOLBELLA® XC With Lidocaine
n=130 Participants
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
|
Total
n=163 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
35.0 years
STANDARD_DEVIATION 8.40 • n=99 Participants
|
35.0 years
STANDARD_DEVIATION 9.83 • n=107 Participants
|
35.0 years
STANDARD_DEVIATION 9.53 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
33 Participants
n=99 Participants
|
130 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
33 Participants
n=99 Participants
|
130 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Lip Fullness Scale (LFS) Score as Assessed by Evaluating Investigator (EI)
Minimal
|
1 Participants
n=99 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
7 Participants
n=107 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
8 Participants
n=206 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
|
Lip Fullness Scale (LFS) Score as Assessed by Evaluating Investigator (EI)
Mild
|
16 Participants
n=99 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
59 Participants
n=107 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
75 Participants
n=206 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
|
Lip Fullness Scale (LFS) Score as Assessed by Evaluating Investigator (EI)
Moderate
|
16 Participants
n=99 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
63 Participants
n=107 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
79 Participants
n=206 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
|
Lip Fullness Scale (LFS) Score as Assessed by Evaluating Investigator (EI)
Marked
|
0 Participants
n=99 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
1 Participants
n=107 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
1 Participants
n=206 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
|
Lip Fullness Scale (LFS) Score as Assessed by Evaluating Investigator (EI)
Very Marked
|
0 Participants
n=99 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
0 Participants
n=107 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
0 Participants
n=206 Participants • mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
|
PRIMARY outcome
Timeframe: Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)Population: mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
The investigator assessed the participant's lip fullness using the 5-point LFS 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). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.
Outcome measures
| Measure |
No-treatment Control
n=29 Participants
No-treatment was administered during control period.
|
JUVÉDERM® VOLBELLA® XC With Lidocaine
n=118 Participants
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
|
|---|---|---|
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Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS)
|
0 percentage of participants
Interval 0.0 to 11.9
|
84.7 percentage of participants
Interval 77.0 to 90.7
|
SECONDARY outcome
Timeframe: Baseline to Month 3 Post TreatmentPopulation: mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of the primary variable. As per protocol, analysis for this Outcome Measure was for the Treatment arm only.
Lip fullness was assessed by the participant using the 5-point LFS 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). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.
Outcome measures
| Measure |
No-treatment Control
n=117 Participants
No-treatment was administered during control period.
|
JUVÉDERM® VOLBELLA® XC With Lidocaine
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
|
|---|---|---|
|
Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS
|
65.0 percentage of participants
Interval 55.6 to 73.5
|
—
|
SECONDARY outcome
Timeframe: Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)Population: mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
Overall lip volume was measured by 3-dimensional (3D) photography images. A positive change from Baseline indicates improvement. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.
Outcome measures
| Measure |
No-treatment Control
n=27 Participants
No-treatment was administered during control period.
|
JUVÉDERM® VOLBELLA® XC With Lidocaine
n=108 Participants
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
|
|---|---|---|
|
Change From Baseline in Overall Lip Volume
|
0.03990 cubic centimeters (cc)
Interval -2.2055 to 0.5676
|
0.45150 cubic centimeters (cc)
Interval -0.8456 to 1.9478
|
SECONDARY outcome
Timeframe: Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)Population: mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
Lips surface area was measured by 3D photography images. A positive percentage change from Baseline indicates improvement. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.
Outcome measures
| Measure |
No-treatment Control
n=29 Participants
No-treatment was administered during control period.
|
JUVÉDERM® VOLBELLA® XC With Lidocaine
n=113 Participants
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
|
|---|---|---|
|
Percentage Change From Baseline in Lip Surface Area
|
-0.11 percentage change in lip surface area
Interval -21.5 to 20.1
|
12.16 percentage change in lip surface area
Interval -9.5 to 76.9
|
SECONDARY outcome
Timeframe: Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with LidocainePopulation: Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. Analysis excludes 11 participants in the No-treatment Control group who did not receive JUVÉDERM® VOLBELLA®.
Procedural pain (pain during injection) was evaluated by the participant using an 11-point scale, where: 0=No pain to 10=Worst pain imaginable. Participants recorded procedural pain in safety diary for 30 days after initial treatment. Number analyzed is the number of participants with safety diary data available for analysis.
Outcome measures
| Measure |
No-treatment Control
n=29 Participants
No-treatment was administered during control period.
|
JUVÉDERM® VOLBELLA® XC With Lidocaine
n=136 Participants
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
|
|---|---|---|
|
Procedural Pain Score
|
2.6 score on a scale
Standard Deviation 1.86
|
2.6 score on a scale
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with LidocainePopulation: Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. Analysis excludes 11 participants in the No-treatment Control group who did not receive JUVÉDERM® VOLBELLA® XC with Lidocaine.
ISRs were recorded by the participant in a safety diary for 30 days after each treatment and were summarized by treatment (initial and touch-up). ISRs were defined as redness, pain after injection, tenderness to touch, firmness, swelling, lumps/bumps, bruising, itching and discoloration. Number analyzed is the number of participants with safety diary data available for analysis.
Outcome measures
| Measure |
No-treatment Control
n=29 Participants
No-treatment was administered during control period.
|
JUVÉDERM® VOLBELLA® XC With Lidocaine
n=136 Participants
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
|
|---|---|---|
|
Number of Participants With Injection Site Responses (ISRs)
Initial Treatment
|
26 Participants
|
123 Participants
|
|
Number of Participants With Injection Site Responses (ISRs)
Touch-up Treatment
|
6 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 12 Post TreatmentPopulation: Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated.
An Adverse event (AE) is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE is an AE that occurred after receiving the first dose of study device or study injection or an AE present prior to first dose but increased in severity during the Treatment Period.
Outcome measures
| Measure |
No-treatment Control
n=40 Participants
No-treatment was administered during control period.
|
JUVÉDERM® VOLBELLA® XC With Lidocaine
n=165 Participants
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
3 Participants
|
74 Participants
|
Adverse Events
No-treatment Control (Control Period)
JUVÉDERM® VOLBELLA® XC With Lidocaine (All Treated)
Serious adverse events
| Measure |
No-treatment Control (Control Period)
n=40 participants at risk
No-treatment was administered during control period.
|
JUVÉDERM® VOLBELLA® XC With Lidocaine (All Treated)
n=165 participants at risk
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
Includes 29 participants in the No-treatment Control arm who received treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine injected into lips after 3 months.
|
|---|---|---|
|
General disorders
Injection site ischaemia
|
0.00%
0/40 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
0.61%
1/165 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/40 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
0.61%
1/165 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/40 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
0.61%
1/165 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/40 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
0.61%
1/165 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/40 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
0.61%
1/165 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/40 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
0.61%
1/165 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/40 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
0.61%
1/165 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
Other adverse events
| Measure |
No-treatment Control (Control Period)
n=40 participants at risk
No-treatment was administered during control period.
|
JUVÉDERM® VOLBELLA® XC With Lidocaine (All Treated)
n=165 participants at risk
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
Includes 29 participants in the No-treatment Control arm who received treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine injected into lips after 3 months.
|
|---|---|---|
|
General disorders
Injection site induration
|
0.00%
0/40 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
14.5%
24/165 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
|
General disorders
Injection site mass
|
0.00%
0/40 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
6.1%
10/165 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
1/40 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
9.7%
16/165 • Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER