NCT03085303已完成不适用
Treatment of Atopic Dermatitis by a Full-Body Blue Light Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 6
- 主要终点
- Change in Eczema Area Severity Index (EASI) at end of treatment
研究概览
简要总结
Multicentric, placebo-controlled, double-blinded, three-armed, prospective, randomized controlled trial.150 patients diagnosed with atopic dermatitis will be randomized to arm 1 (irradiation for 30min at 415nm wavelength), arm 2 (irradiation for 30min at 450nm wavelength), and arm 3 (irradiation for 30min at low-dose (placebo)). Irradiation will be scheduled 3 times a week for 8 weeks. Patients will be followed up for four weeks after the last irradiation.
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)
盲法说明
Patients are blinded by wearing tinted glasses for eye protection which disenable distinction of different wave lengths of light. Medical doctors will examine patients in other rooms than those equipped with the investigational medical devices. These examiners are blinded and are therefore not involved in the preparation and process of the irradiation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent prior to any study mandated procedure
- •Good health as determined by the Investigator
- •Willing and able to comply with study requirements
- •Atopic dermatitis (AD) fulfilling the United Kingdom (UK) criteria of AD
- •Age between 18 and ≤ 75 years
- •Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year; e.g. oral contraceptives, intrauterine device [IUD] or transdermal contraceptive patch)
- •Willing to abstain from excessive sun / UV exposure (e.g. sunbathe, solarium) during the course of the study
- •Body Mass Index ≥ 18 and ≤ 35
排除标准
- •Inmates of psychiatric wards, prisons, or other state institutions
- •Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
- •Participation in another clinical trial within the last 30 days
- •Pregnant or nursing women
- •Risk of non-compliance with study procedures
- •Medical History
- •Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases may include cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease, and others.
- •Clinically relevant abnormalities in hematology, or blood chemistry at screening.
- •Positive HIV-1/2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening.
- •Diastolic blood pressure above 95 mmHg.
- •Febrile illness within 2 weeks prior to baseline visit.
- •Alcohol or drug abuse within 12 months prior to screening (i.e., Regular daily consumption of more than 1 liter of beer or the equivalent quantity of approximately 40 g of alcohol in another form.)
- •Photodermatosis and/or significant photosensitivity, including porphyria and/or hypersensitivity to porphyrins as well as photosensitivity due to present or past (within the last year) intake of amiodarone.
- •Congenital or acquired immunodeficiency
- •Patients who have been diagnosed with invasive skin cancer at any time (=malignant cells invaded below the basal membrane of the epidermis), or with severe actinic damage present at baseline visit.
- •Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer (i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom-Syndrome).
- •Concomitant medication/treatment in medical history and during the study
- •Within 8 weeks prior to baseline visit:
- •Systemic immunosuppression treatment (steroids, cyclosporine, azathioprine, Mycophenolate Mofetil (MMF))
- •Within 4 weeks prior to baseline visit:
- •UV radiation treatment
- •Within 2 weeks prior to baseline visit:
- •Topical steroid treatment
- •Topical calcineurin inhibitor treatment
- •Within 3 days prior to baseline visit:
- •Photo-sensitising medication (e.g. psoralen, tetracyclines, hydrochlorothiazide, phenothiazines, quinolones, hypericumperforatum, arnica, valerian, tar) as assessed by the regular medication plan of the patient
- •colours (e.g. thiazide, toluidine blue, eosin, methylene blue, rose Bengal, acridine) which will be visible on the patient's skin
结局指标
主要结局
Change in Eczema Area Severity Index (EASI) at end of treatment
时间窗: week 8
Change in EASI from baseline to week 8
次要结局
- Change in Investigator Global assessment (IGA)at end of treatment(week 8)
- Change in Score of Atopic Dermatitis (SCORAD) at end of treatment(week 8)
- EASI 50%(week 8)
- Change in Dermatology Life Quality Index (DLQI) at end of treatment(week 8)
- Change in EASI at follow-up(week 12)
- Time until treatment response(week 0-8)
- Change in Patient Oriented Score of Atopic Dermatitis (PO-SCORAD) at end of treatment(week 8)
- Change in itch Visual Analogue Scale (VAS) at end of treatment(week 8)
研究者
研究点 (6)
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