Juläine injections to improve atrophic facial acne scars
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
Run by Nordberg Medical AB · NCT07058883 · Data updated 2026-11-12
This will test whether Juläine injections can improve moderate to severe atrophic facial acne scars in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | Nordberg Medical AB Industry-sponsored |
| Locations | 2 sites (Gdansk and 1 other locations) |
| Status | Recruiting |
| Started | March 13, 2026 |
| Main results expected | December 2026 |
| Study ends | March 2027 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT07058883 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with moderate to severe atrophic facial acne scars who are immune-competent, not pregnant or breastfeeding, and able to attend study visits are the intended participants.
✕Probably not a fit
Those with active acne or infection in the treatment area, a history of keloids or hypersensitivity to device components, bleeding disorders, recent aesthetic treatment in the same area, or who cannot travel to the clinics are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, randomized, double-blind, placebo-controlled trial compares Juläine (a polylactic acid injectable) to saline in adults with moderate to severe atrophic facial acne scars. A total of 55 participants in Poland will be randomized 45:10 and receive three injection sessions over two months (Day 0, Day 30, Day 60) with a 12-month follow-up. The primary outcome is blinded improvement on the Acne Scar Rating Scale at 12 months, with secondary outcomes including patient satisfaction, GAIS ratings, and objective skin texture imaging (e.g., Canfield VISIA), while safety is tracked through adverse events and local tolerability assessments. The study is conducted under ISO 14155 and EU MDR standards and has local ethics committee approval.
Why it matters
Potential benefit: If successful, Juläine could reduce the depth and visibility of atrophic acne scars and improve skin texture and patient satisfaction.
How similar studies have gone: Polylactic acid–based injectable fillers have been used for facial volume and atrophic scars with some positive reports, but controlled long-term data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Individual Specialist Medical Practice Maria Luiza-Piesiaków
Gdansk, Poland Recruiting -
Centrum Medyczne dr Kubik
Gdynia, Poland Recruiting
Study contacts
- Study coordinator: Paweł Kubik, MD, PhD
- Email: pawel.kubik@k-lab.com.pl
- Phone: +48 515 151 388
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.