Juläine injections to improve 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
NA · Nordberg Medical AB · NCT07058883
This will test whether Juläine injections can improve moderate to severe atrophic facial acne scars in adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nordberg Medical AB (industry) |
| Locations | 2 sites (Gdansk and 1 other locations) |
| Trial ID | NCT07058883 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blind, placebo-controlled trial compares Juläine (a polylactic acid injectable) to saline in adults with moderate to severe atrophic facial acne scars. A total of 55 participants in Poland will be randomized 45:10 and receive three injection sessions over two months (Day 0, Day 30, Day 60) with a 12-month follow-up. The primary outcome is blinded improvement on the Acne Scar Rating Scale at 12 months, with secondary outcomes including patient satisfaction, GAIS ratings, and objective skin texture imaging (e.g., Canfield VISIA), while safety is tracked through adverse events and local tolerability assessments. The study is conducted under ISO 14155 and EU MDR standards and has local ethics committee approval.
Who should consider this trial
Good fit: Adults with moderate to severe atrophic facial acne scars who are immune-competent, not pregnant or breastfeeding, and able to attend study visits are the intended participants.
Not a fit: Those with active acne or infection in the treatment area, a history of keloids or hypersensitivity to device components, bleeding disorders, recent aesthetic treatment in the same area, or who cannot travel to the clinics are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, Juläine could reduce the depth and visibility of atrophic acne scars and improve skin texture and patient satisfaction.
How similar studies have performed: Polylactic acid–based injectable fillers have been used for facial volume and atrophic scars with some positive reports, but controlled long-term data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gdansk and 1 other locations
- Individual Specialist Medical Practice Maria Luiza-Piesiaków — Gdansk, Poland (RECRUITING)
- Centrum Medyczne dr Kubik — Gdynia, Poland (RECRUITING)
Study contacts
- Study coordinator: Paweł Kubik, MD, PhD
- Email: pawel.kubik@k-lab.com.pl
- Phone: +48 515 151 388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acne Scars, polylactic acid, facial scars, acne, aesthetic, injectable device