Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars

ConditionAcne Scars
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNordberg Medical AB

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)

Treatment groups

55 Participants
are divided into 2 treatment groups

Sponsors and collaborators