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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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EVOLYSSE PAS


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General
Study Status Ongoing
Application Number /
Requirement Number		 P240022 / PAS001
Date Original Protocol Accepted 04/30/2025
Date Current Protocol Accepted 12/18/2025
Study Name EVOLYSSE PAS
Device Name EVOLYSSE™ SMOOTH and EVOLYSSE™ FORM
Clinical Trial Number(s) NCT05325411 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives Study Design and Objective(s) The post-approval study is a multicenter, prospective, randomized, split face, controlled, double-blind study in adults with Fitzpatrick skin type V or VI desiring correction of moderate or severe nasolabial folds (NLFs) . This study objective is to collect additional safety and effectiveness data on Evolysse Form in darker skin types. To be eligible for the study, subjects were required to have a score of 3 (moderate) or 4 (severe) in both NLFs on the Wrinkle Severity Rating Scale (WSRS).
Study Population Adult Fitzpatrick type V and VI male and female subjects
Sample Size Sample Size Number of subjects: Up to 15
Assumptions for sample size estimation: N/A
Number of sites: 2 US sites
Sites location: US
Key Study Endpoints Study Endpoints Safety Endpoints
- Adverse Events (AE)
- AE of Special Interest (AESI; e.g., visual disturbances)
- Injection Site Responses (ISR)
- Visual assessments (Snellen visual acuity, confrontational visual fields, ocular motility)
- Post-treatment pain assessment

Effectiveness Endpoints
Primary: Independent panel review (IPR) assessments of NLF severity , independently assessed for each side of the face using the validated 5-grade photo numeric WSRS.
Secondary:
- Blinded evaluator (BE) live assessments on the WSRS
- Subject assessment on Global Aesthetic Improvement Scale (GAIS)
- Subject assessment on FACE-Q Appraisal of NLFs
- Subject assessment on FACE-Q Satisfaction with Outcome
Follow-up Visits and Length of Follow-up Frequency of Follow-up Visits and Length of Follow-up Subjects receive initial treatment and optional touch-up treatment at 2 weeks if needed to achieve optimal aesthetic outcome.
Follow-up visits are at 3 days (safety call) and 6, 12, and 24 weeks after the initial treatment.


EVOLYSSE PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/14/2025 08/12/2025 On Time
1 year report 02/13/2026 02/09/2026 On Time
18 month report 08/14/2026    
2 year report 02/13/2027    
3 year report 02/13/2028    


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

Additional Resources

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