EUCTR2004-002478-47-BE进行中（未招募）不适用
Comparative, multicentre, randomised, double-blind study to assess the efficacy of tacrolimus 0.03% ointment versus fluticasone 0.005% ointment in children aged 2 years or over suffering from 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
- 460
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
- •Only those patients complying with the criteria below may be included:
- •-Male or female patients, of any racial origin,
- •-Patients aged between 2 and 15 years (not yet celebrated their 16th birthday) suffering from moderate to severe atopic dermatitis (Rajka & Langeland score = 4.5 – see Annex C) and who have responded insufficiently to conventional therapies.
- •-Female patients of childbearing age must undertake to use, if relevant, effective contraceptive measures throughout the period of the study and for the four weeks following the end of the study.
- •-Children whose parents have signed the informed consent form. In this case, and if the child is capable of understanding the aims and risks inherent in the study, his or her written informed consent should also be obtained.
- •-Patients complying with the following criteria for therapeutic washout:
- •Treatment restrictions prior to the study: Washout period before Day 1
- •Topical corticosteroids: 3 days
- •Systemic corticosteroids for the treatment of atopic dermatitis: 5 days
- •Non-steroidal immunosuppressants (cyclosporin, methotrexate, etc.): 2 weeks
- •Systemic antihistamines: 5 days
- •Other study drugs: 4 weeks
- •UVA/UVB therapy: 4 weeks
- •Treatment with Tacrolimus ointment or Pimecrolimus: 2 weeks
- •Topical antibiotics: 3 days
- •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
- •Patients presenting with any one of the following criteria cannot be included in the study:
- •-Patients with a genetic epidermal barrier defect, such as Netherton's syndrome, or those suffering from erythroderma.
- •-Any female patients who are pregnant or breast-feeding.
- •-Patients presenting with a clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum.
- •-Patients presenting with superinfected eczema.
- •-Patients presenting with known hypersensitivity to macrolides or to any other excipient in tacrolimus ointment.
- •-Patients presenting with known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation.
- •-Patients presenting with ulcerated lesions, of whatever type.
- •-Patients presenting with moderate to severe acne with rosacea.
- •-Patients participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study.
- •-Patients presenting with any type of substance abuse (including that of drugs and alcohol) or any mental disorder/psychological state which, in the investigator's opinion, may interfere with the patient's follow-up.
- •-Patients with known serologically-proven HIV positivity.
研究者
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