EUCTR2004-002477-23-BE进行中（未招募）1 期
Comparative, multicentre, randomised, double-blind study to assess the efficacy of tacrolimus 0.1% ointment versus fluticasone 0.005% ointment in adult patients suffering from moderate to severe atopic dermatitis and presenting with so-called red face lesions of the head and neck
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 510
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 patients who comply with all the criteria below may be included:
- •-Male or female patients, of any racial origin.
- •-Patients over the age of 16 years (after 16th birthday), presenting with moderate to severe atopic dermatitis with lesions to the head and neck defined as red face or facial eczema: erythema affecting at least 10% of the surface of the face (head, neck, chest, nape of neck), accompanied by itching and also, in some cases, by oedema, vesicles, dryness, weeping, crusts and lichenification in a context of longstanding atopic dermatitis, accompanied or not by lesions on the body. These patients have experienced at least two flare-ups of facial eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment has proved ineffective or poorly tolerated.
- •-Female patients of childbearing age must, if relevant, undertake to use effective means of contraception throughout the period of the study and for four weeks following the end of the study.
- •-Patients who have signed the informed consent form (see section 15.3 and Annex G)
- •-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 + 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) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients presenting with at least 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.
- •-Patients presenting with seborrheic dermatitis or contact dermatitis affecting the face, or any other facial erythema of non-atopic origin.
- •-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 0.1% 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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