In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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.
Followup Visits and Length of Followup
The rats will be followed for approximately 91 days.
Final Study Results
Actual Number of Patients Enrolled
10 male rats
Actual Number of Sites Enrolled
1
Patient Followup Rate
100%
Final Safety Findings
Not applicable
Final Effectiveness Findings
Not applicable
Study Strengths and 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.
