NCT00691145已完成3 期
A Long-term, Non-comparative, Multi-centre Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus (FK506) Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis FG-506-06-IT-01
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 主要终点
- The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 6/end of study (if before month 6) visit
研究概览
简要总结
The objective of this study is to assess the efficacy and safety of 0.1% and 0.03% Tacrolimus ointment for 12 months in adults with moderate to severe atopic dermatitis.
详细描述
The main phase is 6 months duration, but the follow up phase up to 12 months will allow the collection of efficacy and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect atopic dermatitis course.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient may be male or female of any ethnic group
- •Patient without restricted legal competence, and suffers from moderate to severe atopic dermatitis (Rajka/Langeland score of at least 4.5)
- •Patient known to be responsive to topical steroids
- •Patient is capable of understanding the purposes and risks of the trial and has given written Informed Consent
- •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
- •Patient meets the following criteria:
- •Topical corticosteroids
- •Systemic corticosteroids (for the treatment of AD only)
- •Systemic non-steroidal immunosuppressants (e.g. cyclosporine, methotrexate)
- •Other investigational drugs
- •Light Treatments (UVA, UVB)
- •Patient has not taken and agrees not to take for the complete study period any medication or therapy prohibited by the protocol
排除标准
- •Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
- •Patient is pregnant or breast-feeding
- •Patient has a skin infection on the affected (and to be treated) area
- •Patient has a known hypersensitivity to macrolides in general, to tacrolimus or any excipient of the ointment
- •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
- •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
- •Patient is known to be HIV positive
研究组 & 干预措施
1
Experimental
干预措施: tacrolimus ointment (Drug)
结局指标
主要结局
The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 6/end of study (if before month 6) visit
时间窗: 1 year
次要结局
- The rate of patients with at least 50%(i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 12/end of study (if after month 6) visit(1 year)
- The rate of patients with at least 60% improvement in the Score In Atopic Dermatitis (SCORAD) at month 6/end of study visit (if before month 6) and at month 12/end of study (if after month 6) visit, each compared to baseline (day 1)(1 year)
- The incidence of adverse events during the study, including all clinically significant laboratory values(1 year)
研究者
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