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

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

NCT Number	NCT06243315
Lead Sponsor	AQTIS Medical B.V.
Conditions	Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the Face
Enrollment	374 participants
Start Date	2023-10-12
Primary Completion	2029-09 (estimated)
Study Completion	2029-09 (estimated)
Updated on ClinicalTrials.gov	2025-04-29