Trial Outcomes & Findings for JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population (NCT NCT04891419)
NCT ID: NCT04891419
Last Updated: 2024-12-12
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
168 participants
Primary outcome timeframe
Up to 14 Months
Results posted on
2024-12-12
Participant Flow
The 168 participants were enrolled and randomized (2:1 ratio) to a 12-month treatment group or a 6-month no-treatment group. Participants who completed the no-treatment group had the option to move to a post-control 6-month treatment group. A total of 112 participants were randomized to the 12-month treatment (JUVÉDERM® VOLUMA® with Lidocaine) group and 56 participants were initially randomized to the no-treatment control group.
Participant milestones
| Measure |
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment.
|
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
56
|
|
Overall Study
Completed the Control Period (Month 1 to 6)
|
107
|
56
|
|
Overall Study
Completed the Post Control Period (Months 7 to 12)
|
107
|
53
|
|
Overall Study
COMPLETED
|
107
|
53
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment.
|
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population
Baseline characteristics by cohort
| Measure |
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
n=56 Participants
No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple.
|
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
n=112 Participants
Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 8.16 • n=5 Participants
|
37.3 years
STANDARD_DEVIATION 9.22 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 8.93 • n=5 Participants
|
|
Age, Customized
< 40 years
|
43 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Age, Customized
40 - 65 years
|
13 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Customized
> 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
56 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Allergan Temple Hollowing Scale
Minimal
|
22 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Allergan Temple Hollowing Scale
Moderate
|
29 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Allergan Temple Hollowing Scale
Severe
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 MonthsPopulation: Control Period - Safety Population
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
Outcome measures
| Measure |
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
n=56 Participants
No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple.
|
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
n=112 Participants
Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment.
|
|---|---|---|
|
Number of Participants With Adverse Events
Any TEAE
|
23 Participants
|
59 Participants
|
|
Number of Participants With Adverse Events
TESAE
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Month 6Population: Control Period - Observed Primary Endpoint Population N = Participants with analysis values at both baseline and Month 6 Visit.
The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
Outcome measures
| Measure |
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
n=56 Participants
No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple.
|
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
n=101 Participants
Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment.
|
|---|---|---|
|
Participants With at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) Using the Allergan Temple Hollowing Scale (ATHS)
|
0 participants
|
92 participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 6Population: Control Period - Modified Intent-to-Treat Population N = Participants with analysis values at both baseline and the specified analysis visits.
Participant-assessed satisfaction using the 12-item FACE-Q Satisfaction with Temples Questionnaire was measured 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 Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
n=56 Participants
No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple.
|
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
n=101 Participants
Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment.
|
|---|---|---|
|
Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6
|
0.1 units on a scale
Standard Deviation 13.97
|
50.7 units on a scale
Standard Deviation 26.06
|
SECONDARY outcome
Timeframe: Change from baseline to Month 6Population: Control Period - Modified Intent-to-Treat Population Participants with analysis values at both baseline and the specified analysis visits.
Participant-assessed satisfaction using the 10-item FACE-Q Satisfaction with Facial Appearance Questionnaire was measured 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 Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
n=56 Participants
No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple.
|
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
n=101 Participants
Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment.
|
|---|---|---|
|
Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6
|
-4.1 units on a scale
Standard Deviation 13.32
|
36.2 units on a scale
Standard Deviation 26.89
|
SECONDARY outcome
Timeframe: Month 6Population: Control Period - Modified Intent-to-Treat Population Participants with analysis values at both baseline and the specified visit.
Participant will assess temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.
Outcome measures
| Measure |
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
n=56 Participants
No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple.
|
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
n=101 Participants
Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment.
|
|---|---|---|
|
Participants "Improved" or "Much Improved" as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS)
|
0 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: Control Period - Modified Intent-to-Treat Population Participants with analysis values at both baseline and the specified visit.
The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.
Outcome measures
| Measure |
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
n=56 Participants
No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple.
|
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
n=101 Participants
Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment.
|
|---|---|---|
|
Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)
|
0 Participants
|
93 Participants
|
Adverse Events
Control - No Treatment (Months 1 - 6)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
JUVÉDERM® VOLUMA® With Lidocaine (Months 1 - 12)
Serious events: 3 serious events
Other events: 62 other events
Deaths: 0 deaths
JUVÉDERM® VOLUMA® With Lidocaine - Post Control (Months 7 - 12)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control - No Treatment (Months 1 - 6)
n=56 participants at risk
No treatment is administered. Optional treatment at Month 6.
|
JUVÉDERM® VOLUMA® With Lidocaine (Months 1 - 12)
n=112 participants at risk
Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment.
|
JUVÉDERM® VOLUMA® With Lidocaine - Post Control (Months 7 - 12)
n=53 participants at risk
Participants will be treated with optional JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple through study exit date.
|
|---|---|---|---|
|
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT
|
0.00%
0/56 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
0.00%
0/53 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
|
Reproductive system and breast disorders
OVARIAN CYST RUPTURED
|
0.00%
0/56 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
0.00%
0/53 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
1.8%
1/56 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
3.8%
2/53 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
Other adverse events
| Measure |
Control - No Treatment (Months 1 - 6)
n=56 participants at risk
No treatment is administered. Optional treatment at Month 6.
|
JUVÉDERM® VOLUMA® With Lidocaine (Months 1 - 12)
n=112 participants at risk
Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment.
|
JUVÉDERM® VOLUMA® With Lidocaine - Post Control (Months 7 - 12)
n=53 participants at risk
Participants will be treated with optional JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple through study exit date.
|
|---|---|---|---|
|
General disorders
INJECTION SITE PAIN
|
0.00%
0/56 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
9.8%
11/112 • Number of events 34 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
1.9%
1/53 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
|
General disorders
INJECTION SITE SWELLING
|
0.00%
0/56 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
6.2%
7/112 • Number of events 17 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
1.9%
1/53 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
|
Infections and infestations
COVID-19
|
32.1%
18/56 • Number of events 18 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
42.0%
47/112 • Number of events 47 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
24.5%
13/53 • Number of events 14 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/56 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
5.4%
6/112 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
1.9%
1/53 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/56 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
0.00%
0/112 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
5.7%
3/53 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
|
Musculoskeletal and connective tissue disorders
TRISMUS
|
0.00%
0/56 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
6.2%
7/112 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
7.5%
4/53 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
|
Nervous system disorders
DIZZINESS
|
1.8%
1/56 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
5.7%
3/53 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.8%
1/56 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
5.4%
6/112 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
0.00%
0/53 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER