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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Clinical PAS

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Application Number P030050 S002/ PAS002
Current Plan Approved 04/23/2014
Study Name OSB Lead-Clinical PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
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.
Sample Size 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.

Data Collection Primary Endpoints:

Safety and effectiveness will be evaluated following the initial treatment regimen of the nasolabial folds.

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.

Secondary Endpoint:

2-year incidence rate of nodules, papules, chronic inflammation and AEs at SCULPTRA Aesthetic injection site

Follow-up Visits and Length of Follow-up 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.

OSB Lead-Clinical PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 mth status report 01/28/2010 01/28/2010 On Time
12 month report 08/05/2010 07/28/2010 On Time
6 month report 12/20/2011 03/15/2012 Overdue/Received
12 month interim report 09/14/2012 09/12/2012 On Time
18 month report 03/15/2013 03/15/2013 On Time
two year report 09/14/2013 09/16/2013 Overdue/Received
six month report 10/30/2014 10/30/2014 On Time
one year report 04/23/2015 04/17/2015 On Time
18 month report 10/23/2015 10/23/2015 On Time
two year report 04/23/2016 04/22/2016 On Time
three year report 04/23/2017    
four year report 04/23/2018    
five year report 04/23/2019    
final report 07/23/2020    

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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