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

NCT ID: NCT07058883

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-03-31

Brief 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.

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of Juläine, a sterile injectable medical device composed of polylactic acid microspheres in a carboxymethylcellulose gel, for the treatment of moderate to severe facial atrophic acne scars.

A total of 55 adult participants will be enrolled across selected dermatology sites in Poland. Forty-five participants will be randomized to receive Juläine, and ten participants will be randomized to receive a placebo (sterile saline solution). All participants will receive three treatment sessions administered over a two-month period (Day 0, Day 30, and Day 60), with injections targeted to areas affected by atrophic scars.

The primary endpoint is the improvement in acne scars at 12 months from baseline, assessed by blinded evaluators using the Acne Scar Rating Scale (ASRS). Secondary outcomes include subject-reported satisfaction, improvement assessments using the Global Aesthetic Improvement Scale (GAIS), and objective skin texture measurements evaluated through imaging systems such as Canfield VISIA.

Safety will be monitored through the collection of adverse events, local tolerability assessments, and follow-up visits over a 12-month period. The study is conducted in compliance with ISO 14155:2020 and EU MDR regulations, and has received ethics approval from the Bioethics Committee of the Regional Medical Chamber in Gdańsk, Poland.

Conditions

Acne Scars

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Juläine

Intervention Type: DEVICE

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

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.

Group Type: PLACEBO_COMPARATOR

Sterile Saline (Placebo)

Intervention Type: OTHER

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

Interventions

Juläine

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

Intervention Type: DEVICE

Sterile Saline (Placebo)

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordberg Medical AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Individual Specialist Medical Practice Maria Luiza-Piesiaków

Gdansk, , Poland

Centrum Medyczne dr Kubik

Gdynia, , Poland

Countries

Poland

Central Contacts

Paweł Kubik, MD, PhD

Role: CONTACT

pawel.kubik@k-lab.com.pl

+48 515 151 388

Facility Contacts

Maria Luiza Piesiaków, MD

Role: primary

maria_luiza@op.pl

+48 515 151 388

Daria Albertyńska, MD

Role: primary

daria.albertynska@drkubik.pl

+48 515 151 388

Other Identifiers

NB 15-TF-EU-100-04F

Identifier Type: -

Identifier Source: org_study_id