Trial Outcomes & Findings for JUVÉDERM® VOLITE™ XC for Cheek Skin Smoothness (NCT NCT03728309)
NCT ID: NCT03728309
Last Updated: 2022-12-19
Results Overview
The ACSS is a validated 5-point ordinal scale developed by Allergan to grade the severity of skin smoothness on the cheeks. The score ranges from 0 (smooth visual skin texture) to 4 (extremely coarse visual skin texture, crosshatched deep creases, extreme elastosis. Responders are participants with at least 1-point improvement (decrease) from baseline on the ACSS on both cheeks based on evaluating investigator (EI) assessment. Baseline is the last non-missing EI assessment on or before the latter of randomization date or first study treatment date in the control period. The multiple imputation method for the missing data imputation was used for analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
209 participants
Primary outcome timeframe
Baseline to Month 1
Results posted on
2022-12-19
Participant Flow
A total of 209 participants were randomized out of which 202 participants were included in (modified intent-to-treat) mITT population.
Participant milestones
| Measure |
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™
Participants received no treatment for up to 30 days and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs and an optional touch-up treatment up to 2 mL 30 days later, if applicable.
|
JUVÉDERM VOLITE™ XC
Participants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL on Day 1 for both cheeks followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment up to 4mL at Month 6, if applicable.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
136
|
|
Overall Study
mITT Population
|
71
|
131
|
|
Overall Study
Volite Treated (VT) Population
|
64
|
135
|
|
Overall Study
VOLITE Repeat Treatment (VRT) Population
|
0
|
79
|
|
Overall Study
COMPLETED
|
61
|
112
|
|
Overall Study
NOT COMPLETED
|
12
|
24
|
Reasons for withdrawal
| Measure |
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™
Participants received no treatment for up to 30 days and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs and an optional touch-up treatment up to 2 mL 30 days later, if applicable.
|
JUVÉDERM VOLITE™ XC
Participants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL on Day 1 for both cheeks followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment up to 4mL at Month 6, if applicable.
|
|---|---|---|
|
Overall Study
Randomized but not Treated
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
8
|
|
Overall Study
Lost to Follow-up
|
9
|
10
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
|
Overall Study
Due to COVID
|
1
|
3
|
Baseline Characteristics
JUVÉDERM® VOLITE™ XC for Cheek Skin Smoothness
Baseline characteristics by cohort
| Measure |
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™
n=71 Participants
Participants received no treatment for up to 30 days and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs and an optional touch-up treatment up to 2 mL 30 days later, if applicable.
|
JUVÉDERM VOLITE™ XC
n=131 Participants
Participants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL on Day 1 for both cheeks followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment up to 4mL at Month 6, if applicable.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 9.42 • n=93 Participants
|
58.0 years
STANDARD_DEVIATION 8.24 • n=4 Participants
|
57.1 years
STANDARD_DEVIATION 8.73 • n=27 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=93 Participants
|
109 Participants
n=4 Participants
|
174 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=93 Participants
|
96 Participants
n=4 Participants
|
146 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=93 Participants
|
115 Participants
n=4 Participants
|
177 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 1Population: mITT Population included all randomized participants who have baseline assessment on the ACSS scale for both cheeks, and are not in the Fitzpatrick V/VI safety cohort. Missing data in ACSS at Month 1 was imputed using the Multiple Imputation method.
The ACSS is a validated 5-point ordinal scale developed by Allergan to grade the severity of skin smoothness on the cheeks. The score ranges from 0 (smooth visual skin texture) to 4 (extremely coarse visual skin texture, crosshatched deep creases, extreme elastosis. Responders are participants with at least 1-point improvement (decrease) from baseline on the ACSS on both cheeks based on evaluating investigator (EI) assessment. Baseline is the last non-missing EI assessment on or before the latter of randomization date or first study treatment date in the control period. The multiple imputation method for the missing data imputation was used for analysis.
Outcome measures
| Measure |
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™
n=71 Participants
Participants received no treatment for up to 30 days and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs and an optional touch-up treatment up to 2 mL 30 days later, if applicable.
|
JUVÉDERM VOLITE™ XC
n=131 Participants
Participants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL on Day 1 for both cheeks followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment up to 4mL at Month 6, if applicable.
|
Treated Period: VOLITE Post-Control Group
After receiving no treatment in the control period, participants received an initial treatment of JUVÉDERM VOLITE™ XC injectable gel up to 4 mL intradermally followed by an optional touch-up treatment 30 days later, if applicable.
|
Repeat Treatment Period: JUVÉDERM® VOLITE™ XC
Participants received an optional repeat treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL at Month 6.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 1-point Improvement (Decrease) From Baseline on the Allergan Cheek Smoothness Scale (ACSS) on Both Cheeks at Month 1
|
4.5 percentage of participants
Interval -0.5 to 9.4
|
57.9 percentage of participants
Interval 49.3 to 66.6
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)Population: Safety Population included all participants who are randomized and received study intervention (VOLITE or no treatment). A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated in the study. Therefore, this participant was included in the treatment group for the mITT population and in the control group for the safety population
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical device which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study device. An AE was considered a treatment emergent adverse event (TEAE) if the AE began or worsened (increased in severity or became serious) after first administration of VOLITE for the treatment group and after the date of randomization for the control group.
Outcome measures
| Measure |
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™
n=74 Participants
Participants received no treatment for up to 30 days and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs and an optional touch-up treatment up to 2 mL 30 days later, if applicable.
|
JUVÉDERM VOLITE™ XC
n=135 Participants
Participants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL on Day 1 for both cheeks followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment up to 4mL at Month 6, if applicable.
|
Treated Period: VOLITE Post-Control Group
n=64 Participants
After receiving no treatment in the control period, participants received an initial treatment of JUVÉDERM VOLITE™ XC injectable gel up to 4 mL intradermally followed by an optional touch-up treatment 30 days later, if applicable.
|
Repeat Treatment Period: JUVÉDERM® VOLITE™ XC
n=79 Participants
Participants received an optional repeat treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL at Month 6.
|
|---|---|---|---|---|
|
Number of Participants Who Experience One or More Treatment Emergent Adverse Event (TEAE)
|
5 Participants
|
14 Participants
|
14 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 1Population: mITT Population included all randomized participants who had baseline assessment on the ACSS scale for both cheeks, and are not in the Fitzpatrick V/VI safety cohort. Number analyzed are the number of participants with data available for analysis at the given timepoint.
The participant assessed satisfaction using the 12 items on the FACE-Q: Satisfaction with Skin questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied. The responses to the 12 items were summed and converted to a scale score that ranges from 0 (worst) to 100 (best). Higher score indicates more satisfaction. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™
n=71 Participants
Participants received no treatment for up to 30 days and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs and an optional touch-up treatment up to 2 mL 30 days later, if applicable.
|
JUVÉDERM VOLITE™ XC
n=131 Participants
Participants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL on Day 1 for both cheeks followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment up to 4mL at Month 6, if applicable.
|
Treated Period: VOLITE Post-Control Group
After receiving no treatment in the control period, participants received an initial treatment of JUVÉDERM VOLITE™ XC injectable gel up to 4 mL intradermally followed by an optional touch-up treatment 30 days later, if applicable.
|
Repeat Treatment Period: JUVÉDERM® VOLITE™ XC
Participants received an optional repeat treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL at Month 6.
|
|---|---|---|---|---|
|
Change From Baseline in Face-Q Satisfaction With Skin Questionnaire at Month 1
Baseline
|
32.5 score on a scale
Standard Deviation 16.53
|
34.3 score on a scale
Standard Deviation 17.11
|
—
|
—
|
|
Change From Baseline in Face-Q Satisfaction With Skin Questionnaire at Month 1
Change from Baseline at Month 1
|
1.4 score on a scale
Standard Deviation 15.18
|
32.0 score on a scale
Standard Deviation 27.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Month 1Population: mITT Population included all randomized participants who had baseline assessment on the ACSS scale for both cheeks, and are not in the Fitzpatrick V/VI safety cohort. Overall number analyzed are the number of participants available for analyses.
The AFLS is a validated 5-point ordinal scale developed by Allergan to grade the severity of fine lines on the cheeks. The score ranges from 0 (no fine lines) to 4 (diffuse superficial lines, crosshatching). Responders are participants with at least 1-point improvement (decrease) from baseline on the AFLS on both cheeks based on observed data of EI assessment. Baseline is the last non-missing EI assessment on or before the latter of randomization date or first study treatment date in the control period.
Outcome measures
| Measure |
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™
n=37 Participants
Participants received no treatment for up to 30 days and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs and an optional touch-up treatment up to 2 mL 30 days later, if applicable.
|
JUVÉDERM VOLITE™ XC
n=84 Participants
Participants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL on Day 1 for both cheeks followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment up to 4mL at Month 6, if applicable.
|
Treated Period: VOLITE Post-Control Group
After receiving no treatment in the control period, participants received an initial treatment of JUVÉDERM VOLITE™ XC injectable gel up to 4 mL intradermally followed by an optional touch-up treatment 30 days later, if applicable.
|
Repeat Treatment Period: JUVÉDERM® VOLITE™ XC
Participants received an optional repeat treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL at Month 6.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 1-Point Improvement (Decreased) From Baseline on Both Cheeks in the Allergan Fine Lines Scale (AFLS) Response at Month 1
|
5.4 percentage of participants
Interval 0.0 to 12.7
|
58.3 percentage of participants
Interval 47.8 to 68.9
|
—
|
—
|
Adverse Events
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treated Period: JUVÉDERM® VOLITE™ XC
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Treated Period: VOLITE Post-Control Group
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Repeat Treatment Period: JUVÉDERM® VOLITE™ XC
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™
n=74 participants at risk
Participants received no treatment for up to 1 month and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs.
|
Treated Period: JUVÉDERM® VOLITE™ XC
n=135 participants at risk
Participants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL on Day 1 followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment at Month 6, if applicable.
|
Treated Period: VOLITE Post-Control Group
n=64 participants at risk
After receiving no treatment in the control period, participants received an initial treatment of JUVÉDERM VOLITE™ XC injectable gel up to 4 mL intradermally followed by an optional touch-up treatment 30 days later, if applicable.
|
Repeat Treatment Period: JUVÉDERM® VOLITE™ XC
n=79 participants at risk
Participants received an optional repeat treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL at Month 6.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.74%
1/135 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/64 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/79 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.74%
1/135 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/64 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/79 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.74%
1/135 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/64 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/79 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.74%
1/135 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/64 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/79 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/135 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/64 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
1.3%
1/79 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/135 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
1.6%
1/64 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/79 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.74%
1/135 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
1.6%
1/64 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/79 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/135 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
1.6%
1/64 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/79 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.74%
1/135 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/64 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/79 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/135 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/64 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
1.3%
1/79 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/135 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/64 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
1.3%
1/79 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
|
Nervous system disorders
HEMIPLEGIA
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/135 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/64 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
1.3%
1/79 • Number of events 1 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
Other adverse events
| Measure |
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™
n=74 participants at risk
Participants received no treatment for up to 1 month and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs.
|
Treated Period: JUVÉDERM® VOLITE™ XC
n=135 participants at risk
Participants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL on Day 1 followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment at Month 6, if applicable.
|
Treated Period: VOLITE Post-Control Group
n=64 participants at risk
After receiving no treatment in the control period, participants received an initial treatment of JUVÉDERM VOLITE™ XC injectable gel up to 4 mL intradermally followed by an optional touch-up treatment 30 days later, if applicable.
|
Repeat Treatment Period: JUVÉDERM® VOLITE™ XC
n=79 participants at risk
Participants received an optional repeat treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 mL at Month 6.
|
|---|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
1.5%
2/135 • Number of events 2 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
4.7%
3/64 • Number of events 3 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/79 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/74 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/135 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
3.1%
2/64 • Number of events 2 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
0.00%
0/79 • From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Safety Population: randomized and received intervention (VOLITE or no treatment) as treated. VT Population: randomized and received VOLITE at the start of the Control Period or received optional VOLITE after the Control Period. VRT Population: all in the VT who received VOLITE repeat treatment. A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated. This participant was in the treatment group for the mITT population and in the control group for the safety population.
|
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