Nasolabial FoldNCT06471933
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
A study testing Juläine in people with Nasolabial Fold, run by Nordberg Medical AB at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Fold
- What is being tested?
- Juläine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Jul 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Male or female, ≥18 years old.
- Immune-competent individuals.
- Presenting NLF contour deficiencies with a WSRS score between 2 (shallow wrinkle) and 4 (deep wrinkle) on both the left and right side of the face.
Who cannot join
- Having received a prior facial surgery for NLF correction, and/or received any local therapeutic treatment (e.g., dermal fillers).
- Having received in the past 2 weeks any local therapeutic treatment of the face below zygomatic arch.
- Pigmentation in NLF or having a history of hypo melanosis.
- Susceptibility to keloid formation or hypertrophic scarring.
- History of a known allergic reaction (e.g., any subject allergic to lidocaine or amide anesthetics, has a history of allergy to Gram-positive bacterial protein, or known to be allergic to any of the constituents of the product: PLLA, sodium carboxymethyl cellulose, mannitol, or sodium hyaluronate).
- History of herpes eruption, or a history of malignant skin disorder, or a history of any other serious disease.
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- Hemorrhagic disease or receiving anti-coagulant therapy.
- Presenting with acute inflammation, infection, or having a history of chronic or recurrent infection potentially affecting the safety or performance of the device or increasing risk for adverse events.
- Having received in the past 2 months immunosuppressant or systemic steroid therapy.
- Having any disease that may affect wound healing, such as connective tissue disorder or serious malnutrition.
- Female who is pregnant and/or lactating
- Any other condition that as judged by the investigator may make follow-up or Investigation procedures inappropriate
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read the 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
- Nasolabial Fold
- Being tested
- Juläine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuläineDevice
Dermal filler (PLLA)
| Study group | Role | What they receive |
|---|---|---|
| Juläine | Experimental | Not described Receives: Device: Juläine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.
Average improvement of at least 1 grade on the WSRS of the combined left and right NLF score.
Score 1-5, Higher scores are a worse outcome.
Measured: 12 months after final injection
Secondary outcomes (7)
Percentage of subjects with improvement of at least 1 grade on the WSRS.
Percentage of subjects with an improvement of at least 1 grade on the WSRS of the left and right (mean of the two) NLF at 3, 6 and 24 months after final injection compared to baseline (investigator assessment at all visits, blinded assessment at 12 months).
Measured: Up to 24 months after final injection
Change in WSRS score
Change in WSRS score of the NLF at 3, 6, 12 and 24 months after final injection compared to baseline.
Score 1-5, Higher scores are a worse outcome.
Measured: Up to 24 months after final injection
Mean WSRS of <2 at each follow-up time
Proportion of subjects with a mean WSRS of <2 at each follow-up time point at 3, 6, 12, and 24 months after final injection.
Measured: Up to 24 months after final injection
Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.
Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.
Measured: Up to 24 months after final injection
Change Face-Q score of Nasolabial Fold
Change in FACE-Q score of the NLF at 6, 12, and 24 months after final injection compared to baseline.
Scores 1-4: high scores better outcome
Measured: Up to 24 months after final injection
Change in Global Aesthetic in Improvement Scale
Change in Global Aesthetic Improvement Scale (GAIS) scores evaluated by the subject, the investigator and a blinded assessor from 2D facial digital imaging at 6, 12, and 24 months after final injection compared to baseline.
Scale 1-5; High scores worse outcome
Measured: Up to 24 months after final injection
Subject Satisfaction Scores
Assessment of Subject Satisfaction Scores at 6, 12, and 24 months after final injection.
Scale 1-5; High scores better outcome
Measured: Up to 24 months after final injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start24 Jul 2024
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordberg Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471933
- Sponsor's protocol ID
- NOR-001
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared due to the proprietary nature of the product under investigation, which is already commercialized. Sharing participant-level data could compromise competitive advantage and intellectual property, and therefore is not aligned with the sponsor's strategic interests.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06471933
- Acronym / sponsor ID
- NOR-001
- Conditions
- Nasolabial Fold
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Nordberg Medical ABIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Juläine | Experimental | Device: Juläine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed Informed Consent Form
- Male or female, ≥18 years old.
- Immune-competent individuals.
- Presenting NLF contour deficiencies with a WSRS score between 2 (shallow wrinkle) and 4 (deep wrinkle) on both the left and right side of the face.
Key exclusion criteria (12 listed)
- Having received a prior facial surgery for NLF correction, and/or received any local therapeutic treatment (e.g., dermal fillers).
- Having received in the past 2 weeks any local therapeutic treatment of the face below zygomatic arch.
- Pigmentation in NLF or having a history of hypo melanosis.
- Susceptibility to keloid formation or hypertrophic scarring.
- History of a known allergic reaction (e.g., any subject allergic to lidocaine or amide anesthetics, has a history of allergy to Gram-positive bacterial protein, or known to be allergic to any of the constituents of the product: PLLA, sodium carboxymethyl cellulose, mannitol, or sodium hyaluronate).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JuläineDermal filler (PLLA) | Device | Juläine |
Primary outcome
Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.
Time frame: 12 months after final injection
Average improvement of at least 1 grade on the WSRS of the combined left and right NLF score. Score 1-5, Higher scores are a worse outcome.
7 secondary outcomes
Percentage of subjects with improvement of at least 1 grade on the WSRS.
Time frame: Up to 24 months after final injection
Change in WSRS score
Time frame: Up to 24 months after final injection
Mean WSRS of <2 at each follow-up time
Time frame: Up to 24 months after final injection
Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.
Time frame: Up to 24 months after final injection
Change Face-Q score of Nasolabial Fold
Time frame: Up to 24 months after final injection
Change in Global Aesthetic in Improvement Scale
Time frame: Up to 24 months after final injection
Subject Satisfaction Scores
Time frame: Up to 24 months after final injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. The IPD will not be shared due to the proprietary nature of the product under investigation, which is already commercialized. Sharing participant-level data could compromise competitive advantage and intellectual property, and therefore is not aligned with the sponsor's strategic interests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juläine in people with Nasolabial Fold, run by Nordberg Medical AB at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade. (time frame: 12 months after final injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.