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 a prospective, open-label; multicenter (at a minimum of 35 sites) US study to
evaluate the long-term safety of Sculptra® Aesthetic (injectable PLLA) in immuno-competent subjects, stratified by Fitzpatrick skin type I-III, IV, and V-VI
Study Population Description
Immuno-competent male or female subjects 18 to 75 years of age with NLF contour deficiencies
and other facial wrinkles as defined by WAS criteria.
Sample Size
Approximately 863 subjects to be enrolled and treated (with a planned minimum of 15 subjects
per site) in order to have 604 evaluable subjects at the end of the study. Minimum of 35 sites.
Data Collection
The co-primary safety endpoints are:
¿ The percentage (incidence rate) of subjects with any injection site
nodule
and/or papule over 5 years.
¿ The percentage (incidence rate) of subjects with any of the following
injection site events over 5 years:
- Hypertrophic scarring
- Keloid formation
- Changes in the skin pigmentation at the site of injection compared to
adjacent skin
- Granuloma (confirmed by a biopsy)
- Skin necrosis
- Hypersensitivity reactions
- Unexpected change in wrinkle contour
The injection site adverse events listed above are defined as adverse events of Property of interest in this study.
The secondary safety endpoints are:
¿ The percentages (incidence rate) of subjects with any injection site nodule
and/or papule; the percentage of subjects who experienced any adverse events
of interest other than nodule or papule over 2 years; location and intervention
for any adverse events of interest; adverse event severity, duration, time to
onset, relationship to Sculptra® Aesthetic and relationship to injection
procedure during the course of the study.
The efficacy endpoints are:
¿ Change from baseline to post-treatment follow-up time points in the WAS at
Month 6, Month 13, and Years 2, 3, 4, and 5.
¿ Investigator/Subject Global Assessments Scores at Month 6, Month 13, and
