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 study is an open-label, multi-center, prospective study designed to assess the safety of EVOLENCE
in subjects with Fitzpatrick skin types IV, V, and VI seeking correction of facial wrinkles.
Study Population Description
The study population is as per device indication. The device is indicated for [add here]
The Study Population includes patients 18 years or older with Fitzpatrick skin types IV, V and VI who have clinical evidence of moderate to deep bilateral wrinkles in the nasolabial area corresponding to a rating of at least 2 on the validated MFWS. Indication: injection into the mid to deep dermis for the correction of moderate to deep facial wrinkles and folds;
Sample Size
165 patients, 10 sites
Data Collection
The effectiveness endpoint is the change in Modified Fitzpatrick Wrinkle Scale at six months. The
safety endpoint is a composite measure of keloid formation and pigmentation change at 6 months post optimal cosmetic results visit.
Followup Visits and Length of Followup
The study required 6 month follow-up. Data collection at office visits included adverse events, Modified
Fitzpatrick Wrinkle Scale. Visits were scheduled at 4 days, 1, 3, 6 months after the last injection.
