Trial Outcomes & Findings for Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Improvement of Volume and Aesthetic Appearance of the Nose in Chinese Adults (NCT NCT03430986)
NCT ID: NCT03430986
Last Updated: 2020-12-30
Results Overview
Volume of the nose was calculated by digital analysis of each participant's 3-dimensional (3D) images. A mixed-effects model for repeated measures (MMRM) was used for analysis. A positive change from Baseline indicates improvement. An analysis model was created by Canfield Scientific, only volume changes are available. Actual Baseline values are not available.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
164 participants
Primary outcome timeframe
Baseline (Last value prior to treatment for the treatment group and last value prior to randomization for control group) to Week 24
Results posted on
2020-12-30
Participant Flow
Participant milestones
| Measure |
No-treatment Control
Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
|
JUVÉDERM® VOLUMA® With Lidocaine
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
|
|---|---|---|
|
24-week Control Period
STARTED
|
42
|
122
|
|
24-week Control Period
Treated as Randomized
|
42
|
120
|
|
24-week Control Period
COMPLETED
|
34
|
118
|
|
24-week Control Period
NOT COMPLETED
|
8
|
4
|
|
24-week Post-Control Period
STARTED
|
31
|
118
|
|
24-week Post-Control Period
COMPLETED
|
30
|
116
|
|
24-week Post-Control Period
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
No-treatment Control
Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
|
JUVÉDERM® VOLUMA® With Lidocaine
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
|
|---|---|---|
|
24-week Control Period
Adverse Event
|
1
|
0
|
|
24-week Control Period
Lost to Follow-up
|
2
|
2
|
|
24-week Control Period
Withdrawal by Participant
|
5
|
0
|
|
24-week Control Period
Protocol Deviation
|
0
|
2
|
|
24-week Post-Control Period
Lost to Follow-up
|
1
|
1
|
|
24-week Post-Control Period
Withdrawal by Participant
|
0
|
1
|
Baseline Characteristics
Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Improvement of Volume and Aesthetic Appearance of the Nose in Chinese Adults
Baseline characteristics by cohort
| Measure |
No-treatment Control
n=37 Participants
Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
|
JUVÉDERM® VOLUMA® With Lidocaine
n=120 Participants
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.9 years
STANDARD_DEVIATION 5.95 • n=93 Participants
|
32.0 years
STANDARD_DEVIATION 10.42 • n=4 Participants
|
31.3 years
STANDARD_DEVIATION 9.63 • n=27 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=93 Participants
|
112 Participants
n=4 Participants
|
147 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
37 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
157 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Chinese
|
37 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
157 Participants
n=27 Participants
|
|
Region of Enrollment
China
|
37 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
157 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (Last value prior to treatment for the treatment group and last value prior to randomization for control group) to Week 24Population: mITT Population included all participants who are randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group) and participants who are randomized to no treatment and complete at least 1 effectiveness assessment (control group).
Volume of the nose was calculated by digital analysis of each participant's 3-dimensional (3D) images. A mixed-effects model for repeated measures (MMRM) was used for analysis. A positive change from Baseline indicates improvement. An analysis model was created by Canfield Scientific, only volume changes are available. Actual Baseline values are not available.
Outcome measures
| Measure |
No-treatment Control
n=37 Participants
Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
|
JUVÉDERM® VOLUMA® With Lidocaine
n=120 Participants
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
|
|---|---|---|
|
Volume Change From Baseline in the Nose Area
|
-0.005 cubic centimeters (cc)
Standard Error 0.1381
|
2.032 cubic centimeters (cc)
Standard Error 0.0764
|
SECONDARY outcome
Timeframe: Week 24Population: mITT Population included all participants who are randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group) and participants who are randomized to no treatment and complete at least 1 effectiveness assessment (control group). Participants analyzed are the number of participants with available data at the given timepoint.
The Evaluating Investigator assessed the aesthetic improvement of the nose using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assessed as 2=much improved or 1=improved is reported.
Outcome measures
| Measure |
No-treatment Control
n=32 Participants
Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
|
JUVÉDERM® VOLUMA® With Lidocaine
n=117 Participants
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
|
|---|---|---|
|
Percentage of Participants Where the Evaluating Investigator Noted "Improved" or "Much Improved Using the Global Aesthetic Improvement Scale (GAIS)
|
18.8 percentage of participants
Interval 7.2 to 36.4
|
87.2 percentage of participants
Interval 79.7 to 92.6
|
SECONDARY outcome
Timeframe: Week 24Population: mITT Population included all participants who are randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group). Participants analyzed is the number of participants with available data at the given timepoint.
The participant assessed the aesthetic improvement of the nose using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved is reported.
Outcome measures
| Measure |
No-treatment Control
n=117 Participants
Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
|
JUVÉDERM® VOLUMA® With Lidocaine
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
|
|---|---|---|
|
Percentage of Participants Who Noted "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS in the Treatment Group
|
91.5 percentage of participants
Interval 84.8 to 95.8
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: mITT Population included all participants who are randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group). Participants analyzed is the number of participants with available data at the given timepoint.
The participant used the 5-point NSS to assess the treatment outcome of the nose where: +2=very satisfied, +1=satisfied, 0=neutral (neither satisfied or dissatisfied), -1=dissatisfied and -2= very dissatisfied. The percentage of participants who assessed themselves as +2=Very Satisfied or +1=Satisfied is reported.
Outcome measures
| Measure |
No-treatment Control
n=117 Participants
Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
|
JUVÉDERM® VOLUMA® With Lidocaine
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
|
|---|---|---|
|
Percentage of Participants Who Noted "Satisfied" or "Very Satisfied" With Treatment Outcome on the Nose Satisfaction Scale (NSS) in the Treatment Group
|
95.7 percentage of participants
Interval 90.3 to 98.6
|
—
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Safety Population included all randomized participants who received VOLUMA treatment in the Control Period (CP) or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment.
An 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.
Outcome measures
| Measure |
No-treatment Control
n=37 Participants
Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
|
JUVÉDERM® VOLUMA® With Lidocaine
n=120 Participants
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Control Period
|
17 Participants
|
43 Participants
|
Adverse Events
No-treatment Control (Control Period)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
JUVÉDERM® VOLUMA® With Lidocaine (Control Period)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
VOLUMA Initially Treated (Post-Control Period)
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
VOLUMA Optionally Treated (Post-Control Period)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No-treatment Control (Control Period)
n=37 participants at risk
Participants who received no treatment during the 24-week Control Period.
|
JUVÉDERM® VOLUMA® With Lidocaine (Control Period)
n=120 participants at risk
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel to the nose area during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
|
VOLUMA Initially Treated (Post-Control Period)
n=118 participants at risk
Participants in the 24-week Post-Control Period who were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period.
|
VOLUMA Optionally Treated (Post-Control Period)
n=31 participants at risk
Participants in the 24-week Post-Control Period who received no treatment in the 24-week Control Period then were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with an optional treatment 8 weeks later, if applicable
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast fibroma
|
2.7%
1/37 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/120 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/118 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/31 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/37 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/120 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.85%
1/118 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/31 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/37 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/120 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.85%
1/118 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/31 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/37 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/120 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/118 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
3.2%
1/31 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/37 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/120 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/118 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
3.2%
1/31 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/37 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/120 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/118 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
3.2%
1/31 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
Other adverse events
| Measure |
No-treatment Control (Control Period)
n=37 participants at risk
Participants who received no treatment during the 24-week Control Period.
|
JUVÉDERM® VOLUMA® With Lidocaine (Control Period)
n=120 participants at risk
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel to the nose area during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
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VOLUMA Initially Treated (Post-Control Period)
n=118 participants at risk
Participants in the 24-week Post-Control Period who were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period.
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VOLUMA Optionally Treated (Post-Control Period)
n=31 participants at risk
Participants in the 24-week Post-Control Period who received no treatment in the 24-week Control Period then were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with an optional treatment 8 weeks later, if applicable
|
|---|---|---|---|---|
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Infections and infestations
Nasopharyngitis
|
13.5%
5/37 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
8.3%
10/120 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
10.2%
12/118 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
12.9%
4/31 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
2/37 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
6.7%
8/120 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
8.5%
10/118 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
9.7%
3/31 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
|
Infections and infestations
Periodontitis
|
5.4%
2/37 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.00%
0/120 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
1.7%
2/118 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
6.5%
2/31 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.4%
2/37 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.83%
1/120 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.85%
1/118 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
6.5%
2/31 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
|
General disorders
Pyrexia
|
2.7%
1/37 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
0.83%
1/120 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
2.5%
3/118 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
|
6.5%
2/31 • JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received treatment.
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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