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NCT Number: NCT07058883

Evaluation of Juläine (TM) for the Treatment of Atrophic 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.

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Key information

Conditions

Acne Scars Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Individual Specialist Medical Practice Maria Luiza-Piesiaków, Gdansk, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Juläine

Device

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

Sterile Saline (Placebo)

Other

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

Primary outcomes

  1. Average change in Acne Scar Rating Scale (ASRS) score from baseline to 6 and 12 months after treatment

    Time frame: 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.

Secondary outcomes

  1. Change in skin elasticity and hydration measured by cutometry

    Time frame: 3, 6, 9, and 12 months after treatment

    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.

  2. Global improvement based on GAIS evaluated by investigator and patient

    Time frame: 3, 6, 9, and 12 months after treatment

    GAIS is a 5-point ordinal scale:

    • = Very much improved
    • = Much improved
    • = Improved
    • = No change
    • = Worse

    Lower scores indicate better aesthetic improvement.

  3. Change in scar structure using high-frequency ultrasound (HFUS)

    Time frame: 12 months after treatment

    Scar depth is measured in millimeters (mm) via HFUS imaging with higher values indicating worse skin condition (more visible features).

  4. Change in skin characteristics evaluated by VISIA imaging

    Time frame: Baseline, 6 months, and 12 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Paweł Kubik, MD, PhD

CONTACT

[email protected]

+48 515 151 388

Sponsors and collaborators

Lead sponsor

Nordberg Medical AB

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 10, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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