Acne ScarsNCT07058883
Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars
A study testing Juläine in people with Acne Scars, run by Nordberg Medical AB at 2 sites in Poland.
Trial summary
This study aims to evaluate the effectiveness and safety of Juläine, an injectable medical device made of polylactic acid, for treating facial acne scars. Participants with atrophic acne scars will be randomly assigned to receive either Juläine or a placebo (saline). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Scars
- What is being tested?
- Juläine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesPoland
- Study dates
- 13 Mar 2026to Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Presence of moderate to severe atrophic facial acne scars
- Immune-competent adult
- Willing and able to comply with study procedures and follow-up visits
- Signed informed consent obtained
Who cannot join
- Active acne, infection, or chronic skin disease in the treatment area
- Known allergy or hypersensitivity to any component of Juläine
- History of keloid formation or hypertrophic scarring
- Current anticoagulant therapy or bleeding disorder
- Pregnant or breastfeeding
- Previous aesthetic treatment in the same area within the past 6 months
- Participation in another interventional clinical trial within 30 days before enrollment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Individual Specialist Medical Practice Maria Luiza-Piesiaków
Gdansk
Maria Luiza Piesiaków, MD, +48 515 151 388, maria_luiza@op.pl
- Recruiting
Centrum Medyczne dr Kubik
Gdynia
Daria Albertyńska, MD, +48 515 151 388, daria.albertynska@drkubik.pl
About this study
Official title: Prospective, Randomized, Placebo-Controlled, Multicenter Clinical Trial Evaluating the Efficacy and Safety of Juläine (Polylactic Acid) in the Treatment of Facial Acne Scars
This study aims to evaluate the effectiveness and safety of Juläine, an injectable medical device made of polylactic acid, for treating facial acne scars. Participants with atrophic acne scars will be randomly assigned to receive either Juläine or a placebo (saline). The treatment will consist of three injection sessions over two months, followed by a 12-month observation period. The study will measure changes in scar severity and skin quality over time using clinical assessments and imaging tools. The study is being conducted at multiple dermatology clinics in Poland and is approved by a local ethics committee.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of Juläine, a sterile injectable medical device composed of polylactic acid microspheres in a carboxymethylcellulose gel, for the treatment of moderate to severe facial atrophic acne scars.
A total of 55 adult participants will be enrolled across selected dermatology sites in Poland. Forty-five participants will be randomized to receive Juläine, and ten participants will be randomized to receive a placebo (sterile saline solution). All participants will receive three treatment sessions administered over a two-month period (Day 0, Day 30, and Day 60), with injections targeted to areas affected by atrophic scars.
The primary endpoint is the improvement in acne scars at 12 months from baseline, assessed by blinded evaluators. Secondary outcomes include subject-reported satisfaction, improvement assessments using the Global Aesthetic Improvement Scale (GAIS), and objective skin texture measurements evaluated through imaging systems such as Canfield VISIA.
Safety will be monitored through the collection of adverse events, local tolerability assessments, and follow-up visits over a 12-month period. The study is conducted in compliance with ISO 14155:2020 and EU MDR regulations, and has received ethics approval from the Bioethics Committee of the Regional Medical Chamber in Gdańsk, Poland.
- Conditions
- Acne Scars
- Being tested
- Juläine, Sterile Saline (Placebo)
- Keywords
- polylactic acid, facial scars, acne, aesthetic, injectable device
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuläineDevice
Juläine is a sterile injectable implant containing poly-L-lactic acid microspheres, intended for intradermal use to improve skin depressions from acne scars.
Sterile Saline (Placebo)Other
Sterile saline solution used as a placebo control, administered in the same volume and schedule as Juläine.
| Study group | Role | What they receive |
|---|---|---|
| Juläine Group | Experimental | Participants in this arm will receive three intradermal injections of Juläine, an injectable polylactic acid gel, at Day 0, Day 30, and Day 60. Injections are administered into areas affected by atrophic acne scars. Receives: Device: Juläine |
| Placebo Group | Placebo comparator | Participants in this arm will receive three intradermal injections of sterile saline (placebo) at Day 0, Day 30, and Day 60, into areas affected by acne scars. Receives: Other: Sterile Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in Acne Scars from baseline to 6 and 12 months after treatment
Average change in acne scars (scale 1-4; higher scores indicate worse scarring) from baseline to 6 and 12 months, assessed by blinded evaluators using photographs.
Measured: 12 months after treatment
Secondary outcomes (3)
Change in skin elasticity and hydration measured by cutometry
Elasticity is expressed in millimeters of skin retraction, with higher values indicating greater elasticity.
Hydration is expressed in arbitrary units (AU), with higher values indicating greater hydration.
Measured: 3, 6, 9, and 12 months after treatment
Global improvement based on GAIS evaluated by investigator and patient
GAIS is a 5-point ordinal scale:
- = Very much improved
- = Much improved
- = Improved
- = No change
- = Worse
Lower scores indicate better aesthetic improvement.
Measured: 3, 6, 9, and 12 months after treatment
Change in scar structure using high-frequency ultrasound (HFUS)
Scar depth is measured in millimeters (mm) via HFUS imaging with higher values indicating worse skin condition (more visible features).
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start13 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 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
- NCT07058883
- Sponsor's protocol ID
- NB 15-TF-EU-100-04F
- Status last verified
- Sep 2026
- First submitted
- 1 Jul 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect participant confidentiality and in compliance with data protection regulations. The study results will be disseminated in aggregate form through peer-reviewed publication and regulatory submissions, ensuring transparency while safeguarding privacy.
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
- Prospective, Randomized, Placebo-Controlled, Multicenter Clinical Trial Evaluating the Efficacy and Safety of Juläine (Polylactic Acid) in the Treatment of Facial Acne Scars
- ClinicalTrials.gov ID
- NCT07058883
- Acronym / sponsor ID
- NB 15-TF-EU-100-04F
- Conditions
- Acne Scars
- Keywords
- polylactic acid, facial scars, acne, aesthetic, injectable device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Nordberg Medical ABIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Jul 2025 (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.
This study aims to evaluate the effectiveness and safety of Juläine, an injectable medical device made of polylactic acid, for treating facial acne scars. Participants with atrophic acne scars will be randomly assigned to receive either Juläine or a placebo (saline). The treatment will consist of three injection sessions over two months, followed by a 12-month observation period. The study will measure changes in scar severity and skin quality over time using clinical assessments and imaging tools. The study is being conducted at multiple dermatology clinics in Poland and is approved by a local ethics committee.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of Juläine, a sterile injectable medical device composed of polylactic acid microspheres in a carboxymethylcellulose gel, for the treatment of moderate to severe facial atrophic acne scars.
A total of 55 adult participants will be enrolled across selected dermatology sites in Poland. Forty-five participants will be randomized to receive Juläine, and ten participants will be randomized to receive a placebo (sterile saline solution). All participants will receive three treatment sessions administered over a two-month period (Day 0, Day 30, and Day 60), with injections targeted to areas affected by atrophic scars.
The primary endpoint is the improvement in acne scars at 12 months from baseline, assessed by blinded evaluators. Secondary outcomes include subject-reported satisfaction, improvement assessments using the Global Aesthetic Improvement Scale (GAIS), and objective skin texture measurements evaluated through imaging systems such as Canfield VISIA.
Safety will be monitored through the collection of adverse events, local tolerability assessments, and follow-up visits over a 12-month period. The study is conducted in compliance with ISO 14155:2020 and EU MDR regulations, and has received ethics approval from the Bioethics Committee of the Regional Medical Chamber in Gdańsk, Poland.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Juläine Group | Experimental | Device: JuläineParticipants in this arm will receive three intradermal injections of Juläine, an injectable polylactic acid gel, at Day 0, Day 30, and Day 60. Injections are administered into areas affected by atrophic acne scars. |
| Placebo Group | Placebo comparator | Other: Sterile Saline (Placebo)Participants in this arm will receive three intradermal injections of sterile saline (placebo) at Day 0, Day 30, and Day 60, into areas affected by acne scars. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Presence of moderate to severe atrophic facial acne scars
- Immune-competent adult
- Willing and able to comply with study procedures and follow-up visits
- Signed informed consent obtained
Key exclusion criteria (7 listed)
- Active acne, infection, or chronic skin disease in the treatment area
- Known allergy or hypersensitivity to any component of Juläine
- History of keloid formation or hypertrophic scarring
- Current anticoagulant therapy or bleeding disorder
- Pregnant or breastfeeding
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 |
|---|---|---|
| JuläineJuläine is a sterile injectable implant containing poly-L-lactic acid microspheres, intended for intradermal use to improve skin depressions from acne scars. | Device | Juläine Group |
| Sterile Saline (Placebo)Sterile saline solution used as a placebo control, administered in the same volume and schedule as Juläine. | Other | Placebo Group |
Primary outcome
Average change in Acne Scars from baseline to 6 and 12 months after treatment
Time frame: 12 months after treatment
Average change in acne scars (scale 1-4; higher scores indicate worse scarring) from baseline to 6 and 12 months, assessed by blinded evaluators using photographs.
3 secondary outcomes
Change in skin elasticity and hydration measured by cutometry
Time frame: 3, 6, 9, and 12 months after treatment
Global improvement based on GAIS evaluated by investigator and patient
Time frame: 3, 6, 9, and 12 months after treatment
Change in scar structure using high-frequency ultrasound (HFUS)
Time frame: 12 months after treatment
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. Individual participant data (IPD) will not be shared to protect participant confidentiality and in compliance with data protection regulations. The study results will be disseminated in aggregate form through peer-reviewed publication and regulatory submissions, ensuring transparency while safeguarding privacy.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juläine in people with Acne Scars, run by Nordberg Medical AB at 2 sites in Poland.
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 5 inclusion and 7 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: looking for participants now, 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 Poland. 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. Some participants in this study may receive a placebo. 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?
Contact Paweł Kubik, MD, PhD (+48 515 151 388, pawel.kubik@k-lab.com.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average change in Acne Scars from baseline to 6 and 12 months after treatment (time frame: 12 months after treatment). 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.