Trial Outcomes & Findings for A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing (NCT NCT03418545)
NCT ID: NCT03418545
Last Updated: 2021-11-15
Results Overview
The evaluating investigator assessed hollowing in both infraorbital areas using the 5-point photonumeric AIHS where: 0=none (no visible hollowing or volume loss medially or laterally), 1=minimal (presence of hollowing with some volume loss medial to the mid-pupillary line; smooth lateral lid-cheek transition), 2=moderate (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss; smooth lateral lid-cheek transition with mild volume loss), 3=severe (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss creating a defined groove along the lid-cheek junction), 4=extreme (defined hollowing extends from medial to lateral canthus; severe volume loss creates a marked step along the lid-cheek junction). The percentage of participants with at least a 1-point improvement change (decrease) in the AIHS is reported.
COMPLETED
PHASE3
163 participants
Baseline (Screening) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC arm) or Month 3 post randomization (No-treatment Control arm)
2021-11-15
Participant Flow
A total of 163 participants were enrolled in the study (signed the informed consent) out of which 140 were randomized to receive JUVÉDERM® VOLBELLA™ XC (treatment group) or no treatment (control group) in 3:1 ratio.
Participant milestones
| Measure |
No-treatment Control
Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
|
JUVÉDERM® VOLBELLA™ XC
JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
105
|
|
Overall Study
Safety Population
|
34
|
105
|
|
Overall Study
Received Optional or Repeat Treatment
|
29
|
37
|
|
Overall Study
COMPLETED
|
30
|
94
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
Reasons for withdrawal
| Measure |
No-treatment Control
Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
|
JUVÉDERM® VOLBELLA™ XC
JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined.
|
|---|---|---|
|
Overall Study
Withdrawal by Participant
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Reason Not Specified
|
0
|
1
|
|
Overall Study
Missing Completion Status
|
0
|
1
|
Baseline Characteristics
A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing
Baseline characteristics by cohort
| Measure |
No-treatment Control
n=32 Participants
Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
|
JUVÉDERM® VOLBELLA™ XC
n=103 Participants
JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 10.85 • n=99 Participants
|
44.9 years
STANDARD_DEVIATION 10.58 • n=107 Participants
|
43.9 years
STANDARD_DEVIATION 10.73 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Screening) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC arm) or Month 3 post randomization (No-treatment Control arm)Population: Modified Intent-to-treat (mITT) Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group), received at least 1 study device treatment and had a Baseline and at least 1 posttreatment assessment of the primary effectiveness variable and participants who were randomized to the control group and had a Baseline and at least 1 follow-up assessment of the primary effectiveness variable.
The evaluating investigator assessed hollowing in both infraorbital areas using the 5-point photonumeric AIHS where: 0=none (no visible hollowing or volume loss medially or laterally), 1=minimal (presence of hollowing with some volume loss medial to the mid-pupillary line; smooth lateral lid-cheek transition), 2=moderate (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss; smooth lateral lid-cheek transition with mild volume loss), 3=severe (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss creating a defined groove along the lid-cheek junction), 4=extreme (defined hollowing extends from medial to lateral canthus; severe volume loss creates a marked step along the lid-cheek junction). The percentage of participants with at least a 1-point improvement change (decrease) in the AIHS is reported.
Outcome measures
| Measure |
No-treatment Control
n=32 Participants
Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
|
JUVÉDERM® VOLBELLA™ XC
n=103 Participants
JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined.
|
|---|---|---|
|
Percentage of Participants With at Least a 1-point Improvement Change From Baseline on the Allergan Infraorbital Hollows Scale (AIHS) Based on Evaluating Investigator's (EI) Assessment
|
15.6 percentage of participants
Interval 3.0 to 28.2
|
83.1 percentage of participants
Interval 75.8 to 90.4
|
SECONDARY outcome
Timeframe: Baseline (Randomization) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC) or Month 3 post randomization (No-treatment Control arm)Population: mITT Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group), received at least 1 study device treatment and had a Baseline and at least 1 posttreatment assessment of the primary effectiveness variable and participants who were randomized to the control group and had a Baseline and at least 1 follow-up assessment of the primary effectiveness variable. Overall number analyzed are the participants with data available for analyses.
The evaluating investigator assessed a participant's global aesthetic improvement in the infraorbital area compared to Baseline using the 5-point GAIS where: 2=much improved (marked improvement in appearance), 1=improved (improvement in appearance, but a touch-up or retreatment is indicated), 0=no change (appearance is essentially the same as the original condition), -1=worse (appearance is worse than the original condition), -2=much worse (appearance is much worse than the original condition). The percentage of participants where the EI selected improved or much improved is reported.
Outcome measures
| Measure |
No-treatment Control
n=32 Participants
Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
|
JUVÉDERM® VOLBELLA™ XC
n=100 Participants
JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined.
|
|---|---|---|
|
Percentage of Participants Improved or Much Improved in the Overall Aesthetic Assessment Based on EI's Assessment of the Global Aesthetic Improvement Scale (GAIS) at Month 3 After the Last Treatment
|
12.5 percentage of participants
Interval 3.5 to 29.0
|
86.0 percentage of participants
Interval 77.6 to 92.1
|
SECONDARY outcome
Timeframe: Baseline (Randomization) to Month 3 post last treatmentPopulation: VOLBELLA™ Initially Treated (VIT) Population included participants who were randomized and received VOLBELLA™ treatment at the beginning of the Control Period. Overall number analyzed are the participants with data available for analyses. The GAIS assessed by the participant was only completed by participants in the JUVÉDERM® VOLBELLA™ XC arm.
The participant assessed their global aesthetic improvement in the infraorbital area compared to Baseline using the 5-point GAIS where: 2=much improved (marked improvement in appearance), 1=improved (improvement in appearance, but a touch-up or retreatment is indicated), 0=no change (appearance is essentially the same as the original condition), -1=worse (appearance is worse than the original condition), -2=much worse (appearance is much worse than the original condition). The percentage of participants who selected improved or much improved is reported.
Outcome measures
| Measure |
No-treatment Control
n=100 Participants
Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
|
JUVÉDERM® VOLBELLA™ XC
JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined.
|
|---|---|---|
|
Percentage of Participants Improved or Much Improved in the Overall Aesthetic Assessment Based on Participant's Assessment of the GAIS at Month 3 After the Last Treatment
|
84.0 percentage of participants
Interval 75.3 to 90.6
|
—
|
SECONDARY outcome
Timeframe: Baseline (Randomization) to Month 3 post last treatmentPopulation: VIT Population included participants who were randomized and received VOLBELLA™ treatment at the beginning of the Control Period. Overall number analyzed are the participants with data available for analyses at Baseline. Number analyzed is the number of participants with data available for analyses at a given time point. The FACE-Q™ was only completed by participants in the JUVÉDERM® VOLBELLA™ XC arm.
Participants assessed their overall satisfaction by using 7 questions on the validated Appraisal of Lower Eyelids module of the FACE-Q™ questionnaire. Each question was answered on a 4-point scale where: 1=not at all, 2=a little, 3=moderately, and 4=extremely bothered. The responses to the items were transformed to create a Rasch transformed score that ranges from 0=worst to 100=best. Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
No-treatment Control
n=104 Participants
Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
|
JUVÉDERM® VOLBELLA™ XC
JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined.
|
|---|---|---|
|
Mean Change From Baseline in Rasch-Transformed Score Based on Participant Responses on the FACE-Q™ Appraisal of Lower Eyelids Questionnaire to Month 3 After the Last Treatment
Baseline
|
54.5 score on a scale
Standard Deviation 14.23
|
—
|
|
Mean Change From Baseline in Rasch-Transformed Score Based on Participant Responses on the FACE-Q™ Appraisal of Lower Eyelids Questionnaire to Month 3 After the Last Treatment
Change From Baseline at Month 3
|
17.8 score on a scale
Standard Deviation 19.80
|
—
|
Adverse Events
No-treatment Control
JUVÉDERM® VOLBELLA™ Initial Treatment
JUVÉDERM® VOLBELLA™ Optional Treatment
JUVÉDERM® VOLBELLA™ Repeat Treatment
Serious adverse events
| Measure |
No-treatment Control
n=34 participants at risk
Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
|
JUVÉDERM® VOLBELLA™ Initial Treatment
n=105 participants at risk
JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator.
|
JUVÉDERM® VOLBELLA™ Optional Treatment
n=29 participants at risk
Participants randomized to the No-treatment Control group received optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel, injected into the infraorbital and adjacent area Month 3 after Randomization as determined by the investigator.
|
JUVÉDERM® VOLBELLA™ Repeat Treatment
n=37 participants at risk
Participants randomized to the JUVÉDERM® VOLBELLA™ XC arm received JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area 12 months after the last treatment as determined by the investigator.
|
|---|---|---|---|---|
|
Infections and infestations
Mastitis
|
0.00%
0/34 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
0.95%
1/105 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
0.00%
0/29 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
0.00%
0/37 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/34 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
0.00%
0/105 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
0.00%
0/29 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
2.7%
1/37 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
Other adverse events
| Measure |
No-treatment Control
n=34 participants at risk
Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
|
JUVÉDERM® VOLBELLA™ Initial Treatment
n=105 participants at risk
JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator.
|
JUVÉDERM® VOLBELLA™ Optional Treatment
n=29 participants at risk
Participants randomized to the No-treatment Control group received optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel, injected into the infraorbital and adjacent area Month 3 after Randomization as determined by the investigator.
|
JUVÉDERM® VOLBELLA™ Repeat Treatment
n=37 participants at risk
Participants randomized to the JUVÉDERM® VOLBELLA™ XC arm received JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area 12 months after the last treatment as determined by the investigator.
|
|---|---|---|---|---|
|
General disorders
Injection site bruising
|
0.00%
0/34 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
0.00%
0/105 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
6.9%
2/29 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
0.00%
0/37 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
|
General disorders
Injection site swelling
|
0.00%
0/34 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
0.00%
0/105 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
6.9%
2/29 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
0.00%
0/37 • From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
|
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