Prospective, Randomized, Placebo-Controlled, Multicenter Clinical Trial Evaluating the Efficacy and Safety of Juläine (Polylactic Acid) in the Treatment of Facial Acne Scars
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Average change in Acne Scar Rating Scale (ASRS) score from baseline to 6 and 12 months after treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Juläine (Device)
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.
干预措施: Sterile Saline (Placebo) (Other)
结局指标
主要结局
Average change in Acne Scar Rating Scale (ASRS) score from baseline to 6 and 12 months after treatment
时间窗: 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.
次要结局
- 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)