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Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars
Sponsor: Nordberg Medical AB
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2026-03-13
Completion Date
2027-03
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
Juläine
Juläine is a sterile injectable implant containing poly-L-lactic acid microspheres, intended for intradermal use to improve skin depressions from acne scars.
Sterile Saline (Placebo)
Sterile saline solution used as a placebo control, administered in the same volume and schedule as Juläine.
Locations (2)
Individual Specialist Medical Practice Maria Luiza-Piesiaków
Gdansk, Poland
Centrum Medyczne dr Kubik
Gdynia, Poland