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Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars

RecruitingNAAges 18 Years - anyAllNordberg Medical AB
NCT07058883 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Juläine
  • Sterile Saline (Placebo)
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Where

2 sites
Individual Specialist Medical Practice Maria Luiza-Piesiaków
Gdansk, Poland
Centrum Medyczne dr Kubik
Gdynia, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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