Acne Scars
Conditions
Keywords
polylactic acid, facial scars, acne, aesthetic, injectable device
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.
Interventions
DEVICEJuläine
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 solution used as a placebo control, administered in the same volume and schedule as Juläine.
Sponsors
Nordberg Medical AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average change in Acne Scar Rating Scale (ASRS) score from baseline to 6 and 12 months after treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in skin elasticity and hydration measured by cutometry | 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. |
| Global improvement based on GAIS evaluated by investigator and patient | 3, 6, 9, and 12 months after treatment | GAIS is a 5-point ordinal scale: 1. = Very much improved 2. = Much improved 3. = Improved 4. = No change 5. = Worse Lower scores indicate better aesthetic improvement. |
| Change in scar structure using high-frequency ultrasound (HFUS) | 12 months after treatment | Scar depth is measured in millimeters (mm) via HFUS imaging with higher values indicating worse skin condition (more visible features). |
| Change in skin characteristics evaluated by VISIA imaging | 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). |
Countries
Poland
Contacts
CONTACTPaweł Kubik, MD, PhD
Outcome results
None listed