The Therapeutic and Preventive Effects of Light-emitting Diodes (LEDs) Irradiation for Post-inflammatory Erythema and Hyperpigmentation: a Self-controlled
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- melanin index
研究概览
简要总结
The aim of this study is to explore the effect of medical LEDs (830 nm and 590 nm) in the prevention and treatment of PIE and PIH.
详细描述
Evidence regarding the efficacy of LEDs for post-inflammatory erythema (PIE) and post-inflammatory hyperpigmentation (PIH) is limited.
The aim of this study was to evaluate the efficacy of 830 nm and 590 nm LED phototherapies on PIE and PIH.
Design of the study:
308 nm LED light (1.5 MED) induced an in vivo PIE/PIH model on the thigh of ten healthy subjects. 830 nm (60 J/cm2) and 590 nm LED (20 J/cm2) were irradiated respectively. For therapeutic irradiation, PIE/PIH model was induced on D1, and LEDs were irradiated on D0, 1, 3, 6 and 8. For preventive irradiation, LEDs were irradiated on D0, 1, 3, 6 and 8 and PIE/PIH model was induced on D9. Erythema index (EI), melanin index (MI), transdermal water loss (TEWL) and C-Cube photography were measured during 10-day follow-up visits.
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Asians;
- •20-65 years old;
- •Fitzpatrick classification III-IV;
- •Sign the informed consent form.
排除标准
- •Have abnormal skin manifestations, such as pigment diseases, photosensitivity diseases and other allergic diseases;
- •Those with a history of abnormal systemic diseases, such as heart disease, liver disease, kidney disease, tumors, and mental illness;
- •Women who are preparing for pregnancy, pregnant or breastfeeding;
- •Have used photosensitizing drugs within two weeks before inclusion in this study;
- •Topical or systemic drugs may be used during this study;
- •bad habits, such as smoking, drinking, etc.;
- •Volunteers who have recently participated in other clinical trials;
结局指标
主要结局
melanin index
时间窗: at day 8
The effect of LED treatment on PIH will be estimated by measure by C-CUBE.
erythema index
时间窗: at day 8
The effect of LED treatment on PIE will be estimated by measure by C-CUBE.
次要结局
- transepidermal water loss (TEWL)(at day 8)
- elasticity(at day 8)
研究者
Yanjun Dan
Department of Dermatology, Huashan Hospital
Huashan Hospital