About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Juläine
- Sterile Saline (Placebo)