EUCTR2015-001040-11-Outside-EU/EEA进行中（未招募）不适用
A Multicentre, Open-Label, Randomized, Controlled Study of Long-Term Intermittent Maintain Treatment with 0.03% Tacrolimus Ointment in Pediatric Patient with Moderate to Severe Atopic Dermatitis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria for period 1:
- •Diagnosed as AD according to Williams diagnostic criteria, and moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland
- •Patients of 2-15 years old, male or female;
- •Patient is able to reach the centre within 3 days in case of a disease exacerbation.
- •A signed informed consent by the patient’s legal representative, if the patient has ability to understand the purpose and risk of the study then a written consent by the patient will also be needed.
- •Inclusion Criteria for period 2:
- •Patients who have completed the Period 1 of the study; and
- •Patients with IGA =2 at the end of Period 1 of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with known allergy to tacrolimus ointment;
- •Patients with serious skin infections in AD skin lesions area;
- •Patients with serious liver and kidney disease, blood system disease, autoimmune disease, chronic severe infections, diabetes, mental illness, and abusing illegal drugs and alcohol sufficient;
- •Patients with malignant tumor or other serious disease which may affect the correct evaluation of efficacy;
- •Patients using local corticosteroids or other immunosuppressive drugs within 1 week, or withdraw time of systematic corticosteroids and other immunosuppressive drugs(cyclosporine, leigongteng, etc.) within 4 weeks;
- •Patients who participated previously in another clinical study within 1 month; and
- •Patients with other reasons for which the investigators consider they should not be enrolled.
研究者
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