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Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
Sponsor: Nordberg Medical AB
Summary
The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine. The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds. Participants will: Receive 3 rounds of treatment and will be followed up for a total of 2 years.
Official title: A Prospective, Single-Arm, Interventional, Multicenter, Post-Market Clinical Follow-up (PMCF) Investigation to Evaluate the Performance and Safety of Injectable Poly-LLactic Acid Dermal Filler for the Treatment of Nasolabial Fold Wrinkles
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
59
Start Date
2024-07-24
Completion Date
2027-06
Last Updated
2025-08-26
Healthy Volunteers
Yes
Conditions
Interventions
Juläine
Dermal filler (PLLA)
Locations (2)
Ribé clinic
Barcelona, Spain
The Faculty
Stockholm, Sweden