Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars
Prospective, Randomized, Placebo-Controlled, Multicenter Clinical Trial Evaluating the Efficacy and Safety of Juläine (Polylactic Acid) in the Treatment of Facial Acne Scars
Nordberg Medical AB
55 participants
Mar 13, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria7
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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 solution used as a placebo control, administered in the same volume and schedule as Juläine.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07058883