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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Pre Clinical PAS

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Study Status Completed
Application Number P030050 S002/ PAS001
Date Current Protocol Accepted 09/09/2010
Study Name OSB Lead-Pre Clinical PAS
General Study Protocol Parameters
Study Design Animal Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description This is an animal study designed to determine the potential visibility of device by various imaging technologies including X-ray computed tomography, radiography, magnetic resonance imaging, and ultrasound imaging at 1 and 90 days after subcutaneous injection to rats. Additionally, injection sites will be microscopically evaluated. all animals will receive the same treatment (subcutenous injection, once on day 1 and once on Day 90 with an Injection volume of 0.2 ml/injection). Injections will be administered to two distinct locations on the dorsal surface of the rat.
Study Population Description 8-9 weeks old male rats [Crl:CD (SD), Charles River, US Raleigh, NC USA]
Sample Size The study includes 10 rats.
Data Collection Bioimaging procedures will be taken on Day 91, approximately 24 hours after 2nd injection.All animals will be anesthetized for the ultrasound imaging and subsequently euthanized for MRI and X-ray CT/radiography procedures. Imaging procedures will be conducted on the two injection sites and one untreated reference site. Images will be evaluated and categorized. A necropsy will be performed on Day 91 to examine the injection and the untreated reference sites by a pathologist.
Follow-up Visits and Length of Follow-up The rats will be followed for approximately 91 days.
Interim or Final Data Summary
Interim Safety Information N/A This is a rat study.
Actual Number of Patients Enrolled 10 male rats
Actual Number of Sites Enrolled 1
Patient Follow-up Rate 100%
Final Safety Findings Not applicable
Final Effect Findings Not applicable
Study Strengths & Weaknesses

Strengths: (1) Phantom studies were conducted for each imaging modality to estimate the possible visualization of the injection sites, (2) Results of the in vivo rat studies are consistent with the results of the phantom studies.

Weaknesses: (1) the absence of objective criteria for determining the adequacy of visualization (2) the results of the imaging studies in this animal model may not predict the outcomes of bioimaging in humans.

Recommendations for Labeling Changes The labeling will be changed to report the objectives, methods and results of the preclinical study; conclusions; and possible implications for clinical practice. The conclusions will state that the sponsor has provided adequate and reasonable data exploring the appearance of Sculptra Aesthetic implants as a function of time and imaging modality. Based on the composition of the device, the visualization of the implant shortly after injection by ultrasound and magnetic resonance imaging (MRI), but not computed tomography (CT) and radiography seems consistent with the poly-lactic acid microparticle / aqueous solution composition. Similarly, the decreased incidence of device visualization at 90 days after implant is consistent with the resorbable nature of the implant.

Implications for Clinical Practice: The study has met its objective of determining the potential visibility of reconstituted Sculptra® Aesthetic with various imaging technologies. The results of the imaging studies in this animal model may not predict the outcomes of bioimaging in humans.

An analysis of the material composing Sculptra® Aesthetic revealed that the material is entirely organic and that it does not appear to contain any metallic or iodine material that would create radiographic contrast to tissue. For this reason conventional radiography is unlikely to visualize the presence of Sculptra Aesthetic in the facial area. Second, PET or other nuclear medicine imaging will not visualize the device because Sculptra Aesthetic¿s components are not radioactive.

OSB Lead-Pre Clinical PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month status report 01/28/2010 01/28/2010 On Time
FINAL REPORT 08/05/2010 08/05/2010 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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