Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars
Trial Parameters
Brief 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). 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
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