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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) of 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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General
Study Status Progress Adequate
Application Number P030050 S002/ PAS002
Date Current Protocol Accepted 05/01/2018
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 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 With 604 evaluable subjects, the study has 80% power to ensure that the upper limit of the observed one-sided 95% confidence interval for the percentage of subjects with any injection site nodule and/or papule adverse event in 5 years will be less than 21% assuming that the actual percentage is p=17% (according to the 17% rate of nodule and/or papule from premarketing study DL6049-0301. The 21% upper bound rate is based upon agreements with FDA).



With 604 evaluable subjects, the study has 99% power to ensure that the upper limit of the observed one-sided 95% confidence interval for the percentage of subjects with any adverse event of interest other than nodule or papule in 5 years will be less than 3% assuming that the actual percentage is p=0.1% (according to the 0% rate of adverse event of interest other than nodule or papule from premarketing study DL6049- 0301. The 3% upper bound rate is based upon agreements with FDA).



The study with 604 evaluable subjects will have an overall power close to 80% to achieve positive results for both the primary hypothesis tests because of 99% power for the second primary hypothesis test.



To ensure sufficient representation of dark skin subjects, the study will have at least 15 subjects with Fitzpatrick skin types IV and 85 subjects with Fitzpatrick skin types V-VI.



Assuming an annual dropout rate of 7% (30% in 5 years), the study will enroll approximately 863 subjects (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 at the end of the study (at least 15 with Fitzpatrick skin type IV and 85 with Fitzpatrick skin type V-VI). When all subjects have completed two years of follow-up, the drop-out rate and other assumptions will be evaluated, and if necessary, additional subjects will be enrolled.

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 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 injection site 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 secondary efficacy endpoints are:

Change from baseline to post-treatment follow-up time points in the Global Assessments Scores (WAS) at Month 6, Month 13, and Years 2, 3, 4, and 5.

Investigator/Subject GAS at Month 6, Month 13, and Years 2, 3, 4, and 5.

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
Report
Date Due
FDA Receipt
Date
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 04/26/2017 Overdue/Received
quarterly report 12/05/2017 12/05/2017 On Time
four year report 04/23/2018 04/19/2018 On Time
five year report 04/23/2019    
six year report 04/23/2020    
final report 08/23/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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