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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P090016 / PAS001 |
| Date Original Protocol Accepted |
11/14/2011
|
| Date Current Protocol Accepted |
12/07/2012
|
| Study Name |
Chemical/Physical Evaluation
|
| Device Name |
BELOTERO BALANCE
|
| Clinical Trial Number(s) |
NCT00876265 NCT00877279
|
| General Study Protocol Parameters |
| Study Design |
Bench/Lab Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Bench/Lab study to evaluate the chemical/physical reasons that the injection force of Belotero Balance decreases as a function of time during product storage.
|
| Study Population |
Not applicable. This is a bench/lab study.
|
| Sample Size |
Not applicable. This is a bench/lab study.
|
| Key Study Endpoints |
Not applicable. This is a bench/lab study.
|
| Follow-up Visits and Length of Follow-up |
Not applicable. This is a bench/lab study.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
n/a - bench study
|
| Actual Number of Sites Enrolled |
n/a - bench study - actual number of batches studied: 3
|
| Patient Follow-up Rate |
The ejection force of three device¿s batches was evaluated in the laboratory during 24 months.
|
| Final Safety Findings |
¿ Over 24 months at room temperature, the ejection force and dynamic viscosity of the product decrease, but remain within the previously set specifications. From a clinical perspective, then, the material is suitable for a 24 month shelf life.
¿ Because only soluble hyaluronic acid (HA) that is a listed ingredient and not a proprietary ingredient was evaluated and not the crosslinked portion, and because the nature of the soluble HA was variable from time point to time point, it is difficult to draw correlations between the viscosity of the material and the network structure/molecular weight distribution of the product. Generally speaking, physical properties arise from chemical characteristics. In this case, there are multiple factors, chiefly the distribution and degradation of the soluble HA component (and secondarily the apparent burst release of soluble HA), that may ultimately lead to the decrease
in material properties.
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| Study Strengths & Weaknesses |
A. Strengths:
¿The evaluation procedures carried out in this study effectively tested stability and ejection force parameters for this device.
¿The study approach was adequate to reveal the behavior and properties of this device at up to 24 months shelf life.
¿The methodology used in this study could be helpful in the evaluation of this class of devices.
B. Limitations
¿The methodology used was limited in scope to evaluate soluble HA that is a listed ingredient and not a proprietary ingredient.
|
| Recommendations for Labeling Changes |
no (No unexpected findings were reported and no additional information from the PAS is needed in the labeling).
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