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.
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
This is a 5-year prospective, open-label, multi-center study to be conducted inthe United States in
35 clinical sites. The overall objective is to assess the post market safety of SCULPTRA Aesthetic in immune- competent subjects when used as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in persons with Fitzpatrick skin types I-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.
863 SCULPTRA Aesthetic naive subjects (including at least 22 with Fitzpatrick skin type IV and 122
with Fitzpatrick skin type V-VI) in order to have a total of 604 evaluable subjects with 5 year follow-up data (including at least 15 with Fitzpatrick skin type IV and 85 with Fitzpatrick skin type V-VI). A minimum of 35 collaborating sites are expected.
Safety and effectiveness will be evaluated following the initial treatment regimen of the nasolabial
Co-Primary Endpoints: 1. 5-year incidence rate of any nodule and/or papule at SCULPTRA Aesthetic injection site.
2. 5-year incidence rate of chronic inflammation adverse events (AEs) other than nodule or papule at SCULPTRA Aesthetic injection site.
2-year incidence rate of nodules, papules, chronic inflammation and AEs at SCULPTRA Aesthetic injection site
Followup Visits and Length of Followup
5 years Following the initial treatment regimen of the nasolabial folds, subjects' safety will be evaluated
at Week 3; Months 3, 6, 9, 13 and then at Years 2, 3, 4, and 5. Subject assessment of effectiveness will be evaluated at Months 6, 13 and then at Years 2, 3, 4 and 5.