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Search / Trial NCT07058883

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

Launched by NORDBERG MEDICAL AB · Jul 1, 2025

Trial Information

Current as of July 25, 2025

Not yet recruiting

Keywords

Polylactic Acid Facial Scars Acne Aesthetic Injectable Device

ClinConnect Summary

This clinical trial is studying a new treatment called Juläine, which is an injectable product designed to improve the appearance of facial acne scars that cause skin to look sunken or pitted. The goal is to see how well Juläine works and if it is safe to use for people with moderate to severe acne scars. Participants in the study will receive either Juläine or a placebo (a harmless saline solution) through three injection sessions over two months. After the treatments, their skin will be checked regularly for up to a year to see how the scars and skin quality change over time.

Adults aged 18 and older who have noticeable acne scars and are healthy enough to take part may be eligible. People with active acne, skin infections, allergies to the treatment, or certain health conditions like bleeding disorders cannot join. Pregnant or breastfeeding women, and anyone who has had recent skin treatments or is in another clinical trial, are also excluded. If you take part, you will need to visit the clinic several times for injections and follow-up check-ups. This study is happening at dermatology clinics in Poland and aims to offer new hope for people looking to improve the look of their acne scars safely.

Gender

ALL

Eligibility 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

About Nordberg Medical Ab

Nordberg Medical AB is a pioneering clinical trial sponsor dedicated to advancing medical research and innovation in the healthcare sector. With a focus on developing cutting-edge therapies and medical devices, the company collaborates with leading research institutions and healthcare professionals to facilitate rigorous clinical studies. Nordberg Medical AB is committed to adhering to the highest ethical standards and regulatory guidelines, ensuring the safety and efficacy of its products. By leveraging state-of-the-art technology and a patient-centered approach, the organization aims to enhance treatment outcomes and improve the quality of life for patients worldwide.

Locations

Gdańsk, , Poland

Gdynia, , Poland

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported