Analysis of Factors Associated With the Efficacy of 595-nm Pulsed Dye Laser Treatment for Rosacea: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical Erythema Assessment (CEA) score
研究概览
简要总结
This study was designed as a single-center, prospective, randomized controlled trial and included 80 patients with rosacea treated at the Department of Dermatology, Jiangsu Provincial People's Hospital. All patients received pulsed dye laser therapy (pulsed dye laser system; Cynosure (Beijing) Medical Technology Co., Ltd., China). Treatment energy was adjusted according to individual clinical responses, with no concomitant therapies administered. All patients were informed of study-related precautions and provided written informed consent prior to enrollment.
Each patient underwent a single session of bilateral facial 595-nm pulsed dye laser treatment with randomized pulse durations of 6 ms or 10 ms, using a fluence of 9-11 J/cm² and a 7-mm spot size, followed by post-treatment epidermal cooling. Skin imaging was performed at baseline and at 1 month after treatment. At 3 and 7 days post-treatment, erythema improvement, pain visual analog scale (VAS) scores, and adverse events were assessed using questionnaires. At 1 month, treatment efficacy and safety were evaluated based on erythema improvement, patient satisfaction, Clinical Erythema Assessment (CEA) score, Investigator's Global Assessment (IGA) score, Rosacea Area and Severity Index (RASI) score, skin imaging analysis, and adverse event records.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants aged 20-60 years with a clinical diagnosis of erythematotelangiectatic rosacea, in otherwise good general health, who provided written informed consent and agreed to complete the study procedures.
排除标准
- •active infection at the treatment site;
- •a history of keloid formation or a tendency to develop keloids;
- •a history of photosensitivity disorders;
- •facial laser treatment, chemical peeling, or facial surgery within the past 3 months;
- •pregnancy or breastfeeding;
- •concomitant treatment for rosacea;
- •participation in another clinical trial within 30 days prior to screening;
- •any other condition deemed by the investigator to make the subject unsuitable for participation;
- •presence of other facial inflammatory skin diseases.
研究组 & 干预措施
6ms-pulse group
干预措施: pulse duration, 6ms (Device)
10ms-pulse group
干预措施: pulse duration, 10ms (Device)
结局指标
主要结局
Clinical Erythema Assessment (CEA) score
时间窗: From enrollment to the end of treatment at 4 weeks
Clinician's Erythema Assessment (CEA) scale Scores 0= clear Clear skin with no signs of erythema 1 = Almost clear Slight redness; almost clear 2=mild Definite redness; mild erythema 3 = moderate Marked redness; moderate erythema 4= severe Fiery redness; severe erythema This scale assesses the average facial erythema condition over 24 hours.For CEA scoring, which were evaluated masked by two well-trained dermatologists. when two dermatologists have different scores, the one with the higher score will be included in the statistics
次要结局
未报告次要终点