Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
NCT06471933 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2026-05-01
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.
Conditions
- Nasolabial Fold
Interventions
- DEVICE
-
Juläine
Dermal filler (PLLA)
Sponsors & Collaborators
-
Nordberg Medical AB
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-07-24
- Primary Completion
- 2026-06-30
- Completion
- 2027-06-30
Countries
- Spain
- Sweden
Study Locations
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