Actively Recruiting
Evaluation of Juläine (Polylactic Acid) for Treating Facial Acne Scars in a Randomized, Placebo-Controlled Clinical Trial
Led by Nordberg Medical AB · Updated on 2026-03-18
55
Participants Needed
2
Research Sites
12 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating Juläine, an injectable medical device made of polylactic acid, for treating moderate to severe atrophic facial acne scars. This randomized, double-blind, placebo-controlled clinical trial involves adult participants and aims to assess the effectiveness and safety of Juläine compared to a placebo. The study is conducted at multiple dermatology clinics in Poland with ethics approval. Participants will be randomly assigned to receive either Juläine or a placebo (sterile saline). Both groups receive three intradermal injections targeted to acne scar areas on Day 0, Day 30, and Day 60. The treatment phase lasts two months, followed by a 12-month observation period to monitor changes in scar appearance and skin quality. During the study, participants will undergo clinical assessments using the Acne Scar Rating Scale, skin elasticity and hydration measurements, imaging with high-frequency ultrasound and VISIA systems, and surveys about satisfaction and improvement. Safety is monitored through adverse event reporting and local tolerability checks throughout the 12-month follow-up. The primary outcome is the change in acne scar severity at 12 months after treatment.
CONDITIONS
Brief Title
Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Moderate to severe atrophic facial acne scars
- Immune-competent adult
- Willing and able to follow study procedures and attend follow-up visits
- Signed informed consent obtained
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 2 months
Participants receive three intradermal injections of either Juläine or placebo into areas affected by atrophic acne scars.
3 treatment visits at Day 0, Day 30, and Day 60
Duration - 12 months
Participants are followed for safety and efficacy assessments including scar improvement, skin elasticity, and imaging over 12 months after treatment.
Follow-up visits at 3, 6, 9, and 12 months after treatment
Trial Site Locations
Total: 2 locations
1
Individual Specialist Medical Practice Maria Luiza-Piesiaków
Gdansk, Poland
Actively Recruiting
2
Centrum Medyczne dr Kubik
Gdynia, Poland
Actively Recruiting
Research Team
P
Paweł Kubik, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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