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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110033 / PAS001 |
| Date Original Protocol Accepted |
10/22/2013
|
| Date Current Protocol Accepted |
10/22/2013
|
| Study Name |
VOLUMA-003 Repeat Treatment Study
|
| Device Name |
JUVEDERM VOLUMA XC
|
| General Study Protocol Parameters |
| Study Design |
Other Study Design
|
| Data Source |
Other Data Source
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Statistical analysis of data collected in the premarket study
|
| Study Population |
Subjects who enrolled in the premarket study and received repeat treatment
|
| Sample Size |
At least 167 modified intent-to-treat (mITT) subjects.
|
| Key Study Endpoints |
Safety Endpoints include: presence, severity, location (zygomaticomalar region, anteromedial cheek, and/or
submalar region), and duration of common treatment site responses (CTRs) and any adverse events (AEs) after repeat treatment. There are no effectiveness endpoints.
|
| Follow-up Visits and Length of Follow-up |
12 months after repeat treatment
1, 3, 6, 9, and 12 months after repeat treatment
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
167
|
| Actual Number of Sites Enrolled |
14
|
| Patient Follow-up Rate |
121/167 (72.5%)
|
| Final Safety Findings |
Primary endpoint was met because the safety profile of VOLUMA XC after repeat treatment was not inferior (or worse) to the safety profile after initial/touch-up treatment. The incidence of early device/injection-related AEs after repeat treatment [8.4% (14/167)] was not significantly greater than the incidence rate for early device/injection-related AEs [33.5% (56/167)]. In fact, the incidence after repeat treatment was statistically significantly lower (25.1%) than the incidence after initial/touch-up treatment.
No new safety concerns were identified after repeat treatment. The types of case reports and adverse events observed after repeat treatment were similar to those after initial/touch-up treatment, but were generally less severe after repeat treatment. Repeat treatment requires smaller doses and it is known that larger injection volumes lead to significantly higher adverse event rates. Therefore, it was expected that the number of adverse events in the repeat treatment post-approval study would decrease.
A multivariate analysis of the data showed that the rate of device/injection-related adverse events increased with injection volume, was higher in females as compared to males and varied from site to site.
|
| Final Effect Findings |
This PAS study did not evaluate effectiveness
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| Study Strengths & Weaknesses |
Strengths: Multi-center, single-blind, randomized, “no-treatment” control group, adequate sample size.
Weaknesses: Low overall follow-up rate (72.5%).
|
| Recommendations for Labeling Changes |
The PAS study design, methods and results must be included in the labeling. Additionally, it should be indicated that multivariate analysis showed that the rate of device/injection-related adverse events was different among clinical sites, increased with larger injection volumes, and was higher in females as compared to males.
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