EUCTR2004-001644-80-HU进行中（未招募）不适用
Clinical study on tacrolimus ointment over the long-termControl Study - Children”Revised version of FG-506-06-39 - Control Study - Children
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
- 200
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
- •1) Patient may be male or female of any ethnic group.
- •2) Patient is aged 2 to 15 years and suffers from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3).
- •3) Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well
- •4) Female patients of childbearing potential must agree to maintain adequate birth control practice during the trial period and during the first four weeks after the end of the study.
- •5) Patient meets the following wash-out criteria at Open Label Day 1 visit:
- •Pre-Study Therapy Restrictions
- •- Topical corticosteroids, topical immunomodulators (except for intranasal/inhaled corticosteroids) = 3 days wash-out period prior to Open Label Day 1
- •- Systemic corticosteroids (for the treatment of AD only) = 5 days wash-out period prior to Open Label Day 1
- •- Systemic non-steroidal immunosuppressants (e.g. ciclosporine, methotrexate) = 2 weeks wash-out period prior to Open Label Day 1
- •- Other investigational drugs = 4 weeks wash-out period prior to Open Label Day 1
- •- Light Treatments (UVA, UVB) = 6 weeks wash-out period prior to Open Label Day 1
- •6) Patient and legal representative(s) agree that the patient will not take for the complete study period any medication or therapy prohibited by the protocol,
- •7) Patient is able to reach the centre within 2 days in case of a disease exacerbation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •1) Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma.
- •2) Patient is pregnant or breast-feeding.
- •3) Patient has a clinically significant skin infection on the affected (and to be treated) area.
- •4) Patient has a known hypersensitivity to macrolides or any excipient of the ointment.
- •5) Patient is simultaneously participating in any other drug trial or less than 28 days have passed between the end of the previous trial and this one.
- •6) Any form of substance abuse (including drug or alcohol abuse) psychiatric disorder or condition which, in the opinion of the investigator, may invalidate the communication with the investigator.
- •7) Patient is known to be HIV positive.
研究者
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