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临床试验/NCT07153679
NCT07153679已完成不适用

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.

Second Affiliated Hospital of Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年1月1日最近更新:
适应症

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

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

发起方
Second Affiliated Hospital of Xi'an Jiaotong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weihui Zeng

professor

Second Affiliated Hospital of Xi'an Jiaotong University

研究点 (1)

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