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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030050 S034/ PAS001 |
| Date Original Protocol Accepted |
01/21/2022
|
| Date Current Protocol Accepted |
|
| Study Name |
Sculptra HF PAS
|
| Device Name |
Sculptra and Sculptra Aesthetic
|
| General Study Protocol Parameters |
| Study Design |
Other Study Design
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Objective: To validate that Sculptra training material reduces use-related risk to an acceptable level.
Design: Test participants will be provided with Sculptra training materials and asked to review the materials. Following training, the participant will exit the study room and a training decay period of one hour will commence. During the decay, the participant will be asked to complete distractor tasks (e.g., complete surveys, puzzles, etc., that are unrelated to Sculptra). Test sessions will be conducted at a research facility in a room set up to simulate a room in a medical spa and will include a table with supplies for reconstituting and a separate area with patient bed where the participant will administer injections to a simulated skin pad placed on the bed. Study participants may sit or stand, based on preference. During a test session, participants will be asked to complete one simulated use scenario. In the scenario, the participant will reconstitute Sculptra then inject prepared Sculptra into an injection pad. Critical tasks related to reconstitution and injection will be evaluated.
|
| Study Population |
Device group: Licensed aesthetic injector (RN/NP/PA or MD/DO) experienced with injecting facial fillers.
Comparator group: None.
|
| Sample Size |
15
|
| Key Study Endpoints |
Evaluation of critical tasks related to correctly reconstituting and injecting Sculptra.
|
| Follow-up Visits and Length of Follow-up |
None
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
15
|
| Actual Number of Sites Enrolled |
1
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| Patient Follow-up Rate |
None
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| Final Safety Findings |
The results from this study show participants were able to reconstitute and inject, following self-guided training, with only a one use-issue attributed to IFU and other use issues attributed to other factors.
|
| Final Effect Findings |
All participants correctly answered all eight knowledge task questions.
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| Study Strengths & Weaknesses |
N/A
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| Recommendations for Labeling Changes |
Labeling should be updated to include pictures of the filler after reconstitution to ensure that users are able to adequately understand and execute the reconstitution procedure correctly.
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