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

NCT07058883 | Recruiting

• 1 other identifier: NB 15-TF-EU-100-04F
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne Scars

Keywords

polylactic acid; facial scars; acne; aesthetic; injectable device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in skin elasticity and hydration measured by cutometry

  3, 6, 9, and 12 months after treatment

• Global improvement based on GAIS evaluated by investigator and patient

  3, 6, 9, and 12 months after treatment

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

  12 months after treatment

• Change in skin characteristics evaluated by VISIA imaging

  Baseline, 6 months, and 12 months

Study Arms (2)

Juläine Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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)

Interventions

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.

Juläine Group

Sterile Saline (Placebo) OTHER

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

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordberg Medical AB: lead

Study Sites (2)

Individual Specialist Medical Practice Maria Luiza-Piesiaków

Gdansk, Poland

RECRUITING

Centrum Medyczne dr Kubik

Gdynia, Poland

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Central Study Contacts

Paweł Kubik, MD, PhD

CONTACT

+48 515 151 388; pawel.kubik@k-lab.com.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: March 13, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)