Evaluation of Juläine (TM) for the Treatment of 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

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.

Study Overview

• Status: Recruiting
• Conditions: Acne Scars
• Intervention / Treatment: Device: Juläine; Other: Sterile Saline (Placebo)

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.

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paweł Kubik, MD, PhD; Phone Number: +48 515 151 388; Email: pawel.kubik@k-lab.com.pl

Study Locations

• Poland
  • Gdansk, Poland
    • Recruiting
    • Individual Specialist Medical Practice Maria Luiza-Piesiaków
    • Contact: Maria Luiza Piesiaków, MD; Phone Number: +48 515 151 388; Email: maria_luiza@op.pl
  • Gdynia, Poland
    • Recruiting
    • Centrum Medyczne dr Kubik
    • Contact: Daria Albertyńska, MD; Phone Number: +48 515 151 388; Email: daria.albertynska@drkubik.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Other: Sterile Saline (Placebo); Sterile saline solution used as a placebo control, administered in the same volume and schedule as Juläine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average change in Acne Scar Rating Scale (ASRS) score from baseline to 6 and 12 months after treatment	Average change in ASRS score (scale 1-4; higher scores indicate worse scarring) from baseline to 6 and 12 months, assessed by blinded evaluators using photographs.	12 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skin elasticity and hydration measured by cutometry	Elasticity is expressed in millimeters of skin retraction, with higher values indicating greater elasticity. Hydration is expressed in arbitrary units (AU), with higher values indicating greater hydration.	3, 6, 9, and 12 months after treatment
Global improvement based on GAIS evaluated by investigator and patient	GAIS is a 5-point ordinal scale: = Very much improved; = Much improved; = Improved; = No change; = Worse Lower scores indicate better aesthetic improvement.	3, 6, 9, and 12 months after treatment
Change in scar structure using high-frequency ultrasound (HFUS)	Scar depth is measured in millimeters (mm) via HFUS imaging with higher values indicating worse skin condition (more visible features).	12 months after treatment
Change in skin characteristics evaluated by VISIA imaging	Skin features assessed using Canfield VISIA focusing on texture, pigmentation, and pores. Scores range from 0 to 100, with higher values indicating worse skin condition (more visible features).	Baseline, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Nordberg Medical AB

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 1, 2025
• First Submitted That Met QC Criteria: July 1, 2025
• First Posted (Actual): July 10, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: aesthetic; acne; polylactic acid; facial scars; injectable device
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Skin and Connective Tissue Diseases; Acne Vulgaris; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: NB 15-TF-EU-100-04F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared to protect participant confidentiality and in compliance with data protection regulations. The study results will be disseminated in aggregate form through peer-reviewed publication and regulatory submissions, ensuring transparency while safeguarding privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No