Poly-L-Lactic Acid: A Comparative Study of Injectable and Thread-Based Delivery in Atrophic Acne Scars
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- change in Goodman and Baron's qualitative grading score
研究概览
简要总结
Background: Management of atrophic acne scars remains challenging due to their heterogeneous morphology and suboptimal response to conventional therapies. Poly-L-lactic acid (PLLA), a biostimulatory agent, promotes neocollagenesis and has emerged as a promising therapeutic option. However, comparative data on different delivery modalities of PLLA and their effects on dermal remodeling and skin physiology remain limited.
Objective: To compare two delivery modalities of PLLA (injectable versus mono-thread) and evaluate their effects on dermal remodeling, clinical outcomes, and safety in atrophic acne scars.
Methods: This prospective split-face study included 24 patients with atrophic acne scars. The right facial side was treated with a single session of PLLA mono-threads, while the left side received two sessions of injectable PLLA at 6-week intervals. Clinical outcomes were assessed using Goodman and Baron's qualitative and quantitative grading systems over a 3-month follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •included adult patients (≥18 years) of both sexes presenting with clinically diagnosed atrophic acne scars (Grades 2-4 according to the Goodman and Baron classification)
排除标准
- •active acne lesions, pregnancy or lactation, bleeding disorders, keloid tendency, systemic diseases affecting wound healing, recent acne scar treatment within the past six months, and known hypersensitivity to PLLA components.
研究组 & 干预措施
injectable PLLA
干预措施: injectable PLLA (Drug)
PLLA threads
干预措施: PLLA threads (Drug)
结局指标
主要结局
change in Goodman and Baron's qualitative grading score
时间窗: 6 months
次要结局
未报告次要终点
研究者
Reham Essam
Ass.prof
Zagazig University