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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P090016 / PAS002 |
| Date Original Protocol Accepted |
11/14/2011
|
| Date Current Protocol Accepted |
03/08/2013
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| Study Name |
Concentration and Molecular Weight
|
| Device Name |
BELOTERO BALANCE
|
| General Study Protocol Parameters |
| Study Design |
Bench/Lab Study
|
| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Detailed Study Protocol Parameters |
| Study Objectives |
Bench/Lab study to evaluate the concentration and molecular weight distribution of low molecular weight hyaluronic acid fragments in Belotero Balance as a function of time.
|
| 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
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| Patient Follow-up Rate |
The concentration and molecular weight distribution of low MW hyaluronic acid (HA) fragments in three Belotero Balance batches are determined in a laboratory study as a function of time during 18 months.
|
| Final Safety Findings |
¿The study results fulfilled the second condition of approval: the sponsor should provide ¿results of studies to evaluate the concentration and molecular weight (MW) distribution of low MW hyaluronic acid (HA) fragments in Belotero Balance as a function of time.¿ HA is a listed ingredient and not a proprietary ingredient. This study reports in each additional time point, during 18 months, additional information about the nature of the soluble fraction HA degradation.
¿Changes in soluble HA fraction are due to degradation of soluble HA within the device, as well as conversion of crosslinked HA to soluble HA. Both effects are linked to hydrolysis of the HA molecule. The mechanism for these increased degradation periods remains unclear.
¿As HA degrades, the % and average MW of the soluble HA fraction increases. However, this increase appears to be temporary as degradation of newly soluble HA occurs. Polydispersity is also lowered as high MW HA fragments degrade over time.
¿Because only soluble HA 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/MW 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 methods used in this study effectively evaluated the concentration and distribution of the MW of HA, and revealed certain empirical information regarding the behavior and properties of this device as it age, particularly the potential for stepwise changes in chemical and mechanical properties.
¿The methodology used in this study could be helpful in the evaluation of this class of devices (HA filler products) and may provide the opportunity to compare results with each other.
B. Weaknesses:
¿The methodology used was limited in scope to evaluate soluble HA.
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| Recommendations for Labeling Changes |
No labeling changes are recommended because no unexpected findings were reported and no additional information from the PAS is needed in the labeling.
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