Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars (NCT07058883) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars
Poland55 participantsStarted 2026-03-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average change in Acne Scar Rating Scale (ASRS) score from baseline to 6 and 12 months after treatment