f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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EVOLENCE


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General
Study Status Terminated
Application Number /
Requirement Number		 P070013 / PAS001
Date Original Protocol Accepted 09/15/2008
Date Current Protocol Accepted 09/15/2008
Study Name EVOLENCE
Device Name EVOLENCE COLLAGEN FILLER
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 Objectives 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 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
Key Study Endpoints 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.
Follow-up Visits and Length of Follow-up 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.


EVOLENCE Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/26/2008 12/23/2008 On Time
1 year report 06/27/2009 06/18/2009 On Time
18 month report 12/26/2009 12/28/2009 Overdue/Received
Final Report 06/27/2010 06/28/2010 Overdue/Received


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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