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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
Individual Specialist Medical Practice Maria Luiza-Piesiaków
RECRUITING
Gdansk
Centrum Medyczne dr Kubik
RECRUITING
Gdynia
Contact Information
Primary
Paweł Kubik, MD, PhD
pawel.kubik@k-lab.com.pl
+48 515 151 388
Time Frame
Start Date: 2026-03-13
Estimated Completion Date: 2027-03
Participants
Target number of participants: 55
Treatments
Experimental: Juläine Group
Participants in this arm will receive three intradermal injections of Juläine, an injectable polylactic acid gel, at Day 0, Day 30, and Day 60. Injections are administered into areas affected by atrophic acne scars.
Placebo_comparator: Placebo Group
Participants in this arm will receive three intradermal injections of sterile saline (placebo) at Day 0, Day 30, and Day 60, into areas affected by acne scars.
Related Therapeutic Areas
Sponsors
Leads: Nordberg Medical AB

This content was sourced from clinicaltrials.gov

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