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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Juläine
DeviceJuläine 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)
Other interventionSterile saline solution used as a placebo control, administered in the same volume and schedule as Juläine.
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: Juläine GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average change in Acne Scars from baseline to 6 and 12 months after treatment
Average change in acne scars (scale 1-4; higher scores indicate worse scarring) from baseline to 6 and 12 months, assessed by blinded evaluators using photographs.
Time frame
12 months after treatmentSecondary outcomes
1
Change in skin elasticity and hydration measured by cutometry
Elasticity is expressed in millimeters of skin retraction, with higher values indicating greater elasticity. Hydration is expressed in arbitrary units (AU), with higher values indicating greater hydration.
Time frame
3, 6, 9, and 12 months after treatment2
Global improvement based on GAIS evaluated by investigator and patient
GAIS is a 5-point ordinal scale: 1. = Very much improved 2. = Much improved 3. = Improved 4. = No change 5. = Worse Lower scores indicate better aesthetic improvement.
Time frame
3, 6, 9, and 12 months after treatment3
Change in scar structure using high-frequency ultrasound (HFUS)
Scar depth is measured in millimeters (mm) via HFUS imaging with higher values indicating worse skin condition (more visible features).
Time frame
12 months after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov