NCT06243315

A Prospective, Multicenter, Post-marketing Clinical Follow-up Research to Evaluate the Long-term Safety of Ellansé-S Dermal Filler Made of PCL Microspheres for the Correction of Moderate-to-severe Nasolabial Folds

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 374 (estimated)
• Sponsor: AQTIS Medical B.V. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This research is intended to evaluate the long-term safety of Ellansé-S PCL dermal filler for the correction of moderate-to-severe NLFs. 374 subjects. This clinical trial is designed as a prospective, multicenter, post-marketing clinical follow-up trial to evaluate the long-term safety of the investigational product, dermal filler made of PCL microspheres, for the correction of moderate-to-severe NLFs

Conditions

• Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the Face

Interventions

Type	Name	Description
DEVICE	Ellansé-S	It is indicated for subcutaneous implantation to correct moderate-to-severe NLFs

Timeline

• Start date: 2023-10-12
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2024-02-06
• Last updated: 2025-04-29

Locations

1 site across 1 country: China