Trial Outcomes & Findings for Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation (NCT NCT00978042)
NCT ID: NCT00978042
Last Updated: 2015-11-03
Results Overview
The primary effectiveness variable was responder rate for the treatment group. The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's overall score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
345 participants
Primary outcome timeframe
6 months
Results posted on
2015-11-03
Participant Flow
345 participants were originally recruited for treatment at 15 sites.
Prior to randomization, 16 patients were excluded as screen failures and the first two participants per site (30 total) were treated as run-in participants. Of the 299 randomized participants, 17 were discontinued prior to treatment, leaving a "modified intent-to-treat" population of 282 participants (235 in Treatment Arm and 47 in Control Arm).
Participant milestones
| Measure |
VOLUMA® XC Treatment Arm
Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
|
Control Arm_No Treatment Then VOLUMA® XC
No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
|
|---|---|---|
|
Initial Treatment Period
STARTED
|
235
|
47
|
|
Initial Treatment Period
MITT_treated With VOLUMA XC
|
235
|
35
|
|
Initial Treatment Period
COMPLETED
|
174
|
32
|
|
Initial Treatment Period
NOT COMPLETED
|
61
|
15
|
|
Received Repeat Treatment
STARTED
|
141
|
26
|
|
Received Repeat Treatment
COMPLETED
|
98
|
23
|
|
Received Repeat Treatment
NOT COMPLETED
|
43
|
3
|
Reasons for withdrawal
| Measure |
VOLUMA® XC Treatment Arm
Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
|
Control Arm_No Treatment Then VOLUMA® XC
No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
|
|---|---|---|
|
Initial Treatment Period
Treated in Error
|
0
|
3
|
|
Initial Treatment Period
Ineligibility
|
1
|
0
|
|
Initial Treatment Period
Lost to Follow-up
|
21
|
3
|
|
Initial Treatment Period
Adverse Event
|
2
|
0
|
|
Initial Treatment Period
Discontinuation by Investigator/Sponsor
|
2
|
0
|
|
Initial Treatment Period
Consent withdrawn
|
22
|
9
|
|
Initial Treatment Period
Other Miscellaneous Reasons
|
13
|
0
|
Baseline Characteristics
Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation
Baseline characteristics by cohort
| Measure |
VOLUMA® XC Treatment Arm
n=235 Participants
Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
|
Control Arm_No Treatment Then VOLUMA® XC
n=47 Participants
No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
|
Total
n=282 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 Years
STANDARD_DEVIATION 7.18 • n=5 Participants
|
54.7 Years
STANDARD_DEVIATION 5.95 • n=7 Participants
|
54.4 Years
STANDARD_DEVIATION 6.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
189 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
208 participants
n=5 Participants
|
41 participants
n=7 Participants
|
249 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
27 participants
n=5 Participants
|
6 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to treatment who received treatment and all participants randomized to "no treatment" control arm, with data available for analysis.
The primary effectiveness variable was responder rate for the treatment group. The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's overall score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments.
Outcome measures
| Measure |
VOLUMA® XC Treatment Arm
n=209 Participants
Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
|
Control Arm_No Treatment Then VOLUMA® XC
n=36 Participants
No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
|
|---|---|---|
|
Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS)
|
85.6 percentage of responders
Only a 97.5% Confidence Interval was calculated = 79.33% to 90.64%.
|
38.9 percentage of responders
Only a 97.5% Confidence Interval was calculated = 21.33% to 58.82%.
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to the treatment arm who received treatment and all participants randomized to "no treatment" control arm who received treatment, with data available for analysis.
Duration of treatment effect was determined by Kaplan-Meier (KM) product limit estimate of the percentage of participants in the treatment group that maintained at least a 1-point improvement in the overall mid-face volume deficit score on the Mid-Face Volume Deficit Scale (MFVDS) based on the average of the 2 blinded Evaluating Investigators' assessments (with 95% Greenwood's Confidence Interval).
Outcome measures
| Measure |
VOLUMA® XC Treatment Arm
n=235 Participants
Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
|
Control Arm_No Treatment Then VOLUMA® XC
n=35 Participants
No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
|
|---|---|---|
|
Duration of Treatment Effect
|
44.6 Percentage of participants
Interval 37.31 to 51.87
|
44.9 Percentage of participants
Interval 27.76 to 62.14
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis.
The investigator evaluated the patient's overall mid-face volume using the GAIS 5-point scale where: 2=much improved to -2=much worse. To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's overall score on GAIS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments.
Outcome measures
| Measure |
VOLUMA® XC Treatment Arm
n=209 Participants
Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
|
Control Arm_No Treatment Then VOLUMA® XC
No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
|
|---|---|---|
|
Responder Rate Based on Improvement in Score on Global Aesthetic Improvement Scale (GAIS)
|
81.8 Percentage of responders
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis.
The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's respective mid-facial area score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. The percentage of responders is categorized by facial region.
Outcome measures
| Measure |
VOLUMA® XC Treatment Arm
n=209 Participants
Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
|
Control Arm_No Treatment Then VOLUMA® XC
No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
|
|---|---|---|
|
Responder Rate Based on Improvement in Score on MFVDS by Facial Region
Zygomaticomalar Region
|
75.6 percentage of responders
|
—
|
|
Responder Rate Based on Improvement in Score on MFVDS by Facial Region
Anteromedial Cheek
|
83.3 percentage of responders
|
—
|
|
Responder Rate Based on Improvement in Score on MFVDS by Facial Region
Submalar Region
|
77.0 percentage of responders
|
—
|
Adverse Events
All Treated Participants_ AEs Initial Treatment
Serious events: 11 serious events
Other events: 98 other events
Deaths: 0 deaths
All Treated Participants_ AEs After Repeat Treatment
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Treated Participants_ AEs Initial Treatment
n=270 participants at risk
All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). AEs reported are AEs with onset prior to retreatment.
|
All Treated Participants_ AEs After Repeat Treatment
n=167 participants at risk
All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) and who received re-treatment. AEs reported are AEs with onset after retreatment.
|
|---|---|---|
|
General disorders
Inflammation
|
0.37%
1/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.00%
0/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
General disorders
Injection site mass
|
0.37%
1/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.00%
0/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.74%
2/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.00%
0/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.37%
1/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.00%
0/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.37%
1/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.00%
0/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.37%
1/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.00%
0/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.37%
1/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.00%
0/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
Eye disorders
Optic neuropathy
|
0.37%
1/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.00%
0/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
Infections and infestations
Appendicitis
|
0.37%
1/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.00%
0/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.37%
1/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.00%
0/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.37%
1/270 • Number of events 1 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.60%
1/167 • Number of events 1 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.37%
1/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.00%
0/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.60%
1/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
Other adverse events
| Measure |
All Treated Participants_ AEs Initial Treatment
n=270 participants at risk
All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). AEs reported are AEs with onset prior to retreatment.
|
All Treated Participants_ AEs After Repeat Treatment
n=167 participants at risk
All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) and who received re-treatment. AEs reported are AEs with onset after retreatment.
|
|---|---|---|
|
General disorders
Injection site mass
|
20.0%
54/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
4.8%
8/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
General disorders
Injection site induration
|
14.4%
39/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
4.2%
7/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
General disorders
Injection site swelling
|
7.8%
21/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.60%
1/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
|
General disorders
Injection site pain
|
6.3%
17/270 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
0.60%
1/167 • 30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. More than 1 event can occur in 1 participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee As this study involves multiple centers, no individual publications will be allowed prior to completion of the final report of the multicenter study except as agreed with Allergan.
- Publication restrictions are in place
Restriction type: OTHER