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.
• 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