Efficacy and Safety of a 1064-nm Nd:YAG Picosecond Laser Versus a 1927-nm Fractional Thulium Laser for Atrophic Acne Scars in Asian Skin: A Randomized, Split-Face, Evaluator-Blinded Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- ECCA grading scale
研究概览
简要总结
Atrophic acne scars are common disfiguring skin problems, especially in the Asian population prone to Post-inflammatory Hyperpigmentation (PIH), and their treatment is highly challenging. 1064 nm microlens array picosecond laser (P-MLA) based on optomechanical effect and 1927 nm segmented thulium laser (FTL) based on photothermal effect are two emerging therapeutic techniques, but there is a lack of strict clinical evidence for direct comparison in the Asian population. This study aims to directly compare the clinical efficacy, safety and tolerability of 1064 nm P-MLA and 1927 nm FTL in the treatment of atrophic acne scars in the Asian population through a randomized, half-face controlled, evaluator blind trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, 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
- 否
入选标准
- •Aged between 18 and
- •Symmetrical atrophic acne scars on both sides of the face.
排除标准
- •Uncontrolled active acne.
- •Pregnant and lactating women.
- •Infectious skin diseases at the treatment site.
- •Have taken retinoid drugs orally within the past 6 months.
- •Photosensitive individuals or those who have used photosensitive drugs within 2 weeks.
- •Keloid constitution.
结局指标
主要结局
ECCA grading scale
时间窗: Baseline and 20 weeks.
Scar shape: U-shaped sharp-edged scars (2-4 mm) = 20 points, irregular U-shaped (\>4 mm) = 25 points. Scar number: 0 scars = 0, ≤5 scars = 1, 6-20 scars = 2, \>20 scars = 3. ECCA score = Shape score × Number score. Higher score = more severe scarring.
GAIS score
时间窗: Baseline and 20 weeks.
GAIS score: 1 = 0%-25% improvement; 2 = 26%-50%; 3 = 51%-75%; 4 = 76%-100%. Higher score = better improvement.
次要结局
- Melanin Index(Baseline and 20weeks.)
- Erythema Index(Baseline and 20 weeks.)
- Transepidermal Water Loss(Baseline and 20 weeks.)
研究者
Weihui Zeng
professor
Second Affiliated Hospital of Xi'an Jiaotong University