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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Juläine
  Juläine is a sterile injectable implant containing poly-L-lactic acid microspheres, intended for intradermal use to improve skin depressions from acne scars.
• Другое Sterile Saline (Placebo)
  Sterile saline solution used as a placebo control, administered in the same volume and schedule as Juläine.

Первичные конечные точки

• Average change in Acne Scar Rating Scale (ASRS) score from baseline to 6 and 12 months after treatment [Срок оценки: 12 months after treatment]

Вторичные конечные точки (4)

• Change in skin elasticity and hydration measured by cutometry [Срок оценки: 3, 6, 9, and 12 months after treatment]
• Global improvement based on GAIS evaluated by investigator and patient [Срок оценки: 3, 6, 9, and 12 months after treatment]
• Change in scar structure using high-frequency ultrasound (HFUS) [Срок оценки: 12 months after treatment]
• Change in skin characteristics evaluated by VISIA imaging [Срок оценки: Baseline, 6 months, and 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Польша · 2 центра

• Individual Specialist Medical Practice Maria Luiza-Piesiaków — Gdansk
• Centrum Medyczne dr Kubik — Gdynia

Идентификаторы

NCT: NCT07058883 · NB 15-TF-EU-100-04F

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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