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RECRUITING
NCT07058883
NA

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

Sponsor: Nordberg Medical AB

View on ClinicalTrials.gov

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.

Official title: Prospective, Randomized, Placebo-Controlled, Multicenter Clinical Trial Evaluating the Efficacy and Safety of Juläine (Polylactic Acid) in the Treatment of Facial Acne Scars

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2026-03-13

Completion Date

2027-03

Last Updated

2026-03-18

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Juläine

Juläine is a sterile injectable implant containing poly-L-lactic acid microspheres, intended for intradermal use to improve skin depressions from acne scars.

OTHER

Sterile Saline (Placebo)

Sterile saline solution used as a placebo control, administered in the same volume and schedule as Juläine.

Locations (2)

Individual Specialist Medical Practice Maria Luiza-Piesiaków

Gdansk, Poland

Centrum Medyczne dr Kubik

Gdynia, Poland