NCT00690105已完成4 期
Comparative, Multicentre, Randomized, 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
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 577
- 主要终点
- Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their local mEASI score (mLEASI) compared to Baseline (day 1).
研究概览
简要总结
Patients with facial atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed or change for the other ointment.
详细描述
Treatments were to be applied twice daily over all lesions on the face (except for the eyelids) until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe AD (Rajka & Langeland score) 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), due to long-term AD
- •At least two flare-ups of 'facial' eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment had proved ineffective or poorly tolerated
- •Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study
- •Informed consent
- •Therapeutic washout for atopic dermatitis treatments
排除标准
- •Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma
- •Seborrheic dermatitis or contact dermatitis affecting the 'face', or any other facial erythema of non-atopic origin
- •Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum
- •Superinfected eczema
- •Known hypersensitivity to macrolides or to any other excipient in tacrolimus 0.1% ointment
- •Known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation
- •Ulcerated lesions, of whatever type
- •Moderate to severe acne or rosacea
- •Patients who participated at the same time in another clinical study or who had participated in another clinical study within 28 days prior to inclusion in the study
- •Any type of substance abuse (including that of drugs and alcohol) or any mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
- •Serologically-proven HIV positivity
研究组 & 干预措施
A
Experimental
干预措施: tacrolimus 0.1% (Drug)
B
Active Comparator
干预措施: fluticasone 0.005 % (Drug)
结局指标
主要结局
Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their local mEASI score (mLEASI) compared to Baseline (day 1).
时间窗: 3 weeks
次要结局
- Assessment of facial pruritus at day 1, day 7 and day 21(1 week and 3 weeks)
- Number of patients using the ointment from the other group to treat facial lesions after day 21(3 weeks)
- Incidences of adverse events during the study period(6 weeks)
- Patient's quality of life at day 1 and day 21(1 week and 3 weeks)
- Quality of sleep at day 1, day 7 and day 21(1 week and 3 weeks)
- Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21(1 week and 3 weeks)
- Global assessment of clinical response on the 'face' by the physician at day 7 and day 21(1 week and 3 weeks)
- Global assessment of clinical response on the 'face' by the patient at day 7 and day 21(1 week and 3 weeks)
- mLEASI score values at day 7 and day 21(1 week and 3 weeks)
- Physician's assessment of individual signs(1 week and 3 weeks)
- Affected surface area assessment at day 1, day 7 and day 21(1 week and 3 weeks)
研究者
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