Trials / Active Not Recruiting
Active Not RecruitingNCT06471933
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 59 (estimated)
- Sponsor
- Nordberg Medical AB · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Juläine | Dermal filler (PLLA) |
Timeline
- Start date
- 2024-07-24
- Primary completion
- 2026-06-01
- Completion
- 2027-06-01
- First posted
- 2024-06-24
- Last updated
- 2025-08-26
Locations
2 sites across 2 countries: Spain, Sweden
Source: ClinicalTrials.gov record NCT06471933. Inclusion in this directory is not an endorsement.