Efficacy of 595 nm Pulsed-dye Laser as an Adjunctive Treatment of Discoid Lupus Erythematosus, A Randomized, Patient/Assessor Blinded Placebo Control Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- erythema index (EI)
研究概览
简要总结
forty DLE lesions from patients will be recruited in the study. The lesions on one side of the body were block-randomized into the treatment group and the other side served as a control. The patients can continue their systemic treatments and the PDL is designed to be used as an adjunctive treatment. Treatments with the PDL will be delivered in the treatment group every 4 weeks for 4 consecutive months while the lesions in the control group received a sham. The patients will be evaluated at baseline (week 0), week 4, 8, 12, and at follow-up period of 4, 12 weeks after the final treatment (week 16, 24). Erythema index (EI), Texture index (TI) will be obtained and digital photographs will be taken and modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI) will be assessed in every visit. The digital photographs will later be evaluated by 3-blinded dermatologists. Moreover, side effects and patients' satisfaction score will also be recorded.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Has at least two DLE lesions, located in the same anatomical location of the body, which the different of mCLASI are not more than 1 point
- •Dose not undergo any procedure or laser treatment within 4 weeks before entered the study
- •Dose not received any localised therapy of DLE eg. topical corticosteriod/immunomodulator within 4 weeks before entered the study
- •Dose not receive the topical chemical peeling within 4 weeks before entered the study
- •Has already received at least 1 systemic standard treatment for DLE and continue until the rest of the study
- •Can follow the study's protocol
排除标准
- •Pregnancy or lactation
- •History of skin cancer
- •History of photo allergy
- •History of bleeding tendency
- •History of abnormal wound healing
结局指标
主要结局
erythema index (EI)
时间窗: week 0(baseline), 4, 8, 12, 16, 24
Comparing changes of EI from baseline between treated group and controlled group, measured by Antera 3D camera
次要结局
- modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI)(week 0, 4, 8, 12, 16, 24)
- Physician Global Assessment (PGA) scores(week 0, 4, 8, 12, 16, 24)
- texture index (TI)(week 0, 4, 8, 12, 16, 24)
研究者
Pawinee Rerknimitr
Assistant Professor
Chulalongkorn University