A Long-term, Non-comparative Study to Evaluate the Safety and Efficacy of Tacrolimus Oint¬Ment in Paediatric Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Assess safety from observations of adverse events, laboratory examinations, pulse, height, weight and tacrolimus blood concentrations
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.
详细描述
This is a long-term, multi-centre, non-comparative phase II study. All centres participating in the FG-506-06-32 pharmacokinetics study will be offered the protocol as a follow-up. Only patients enrolled by those centres for the above mentioned study, who applied at least one dose of study medication and benefited from treatment with 0.03% tacrolimus ointment, can be enrolled.
During episodes of active disease, a thin coat of ointment is applied on each lesion. In the first three weeks, frequency of application is twice a day; after three weeks treatment is continued once a day. All atopic dermatitis lesions are treated until clearance (i.e. itch has gone). In case of a flare-up or worsening treatment twice daily treatment is re-started for three weeks and thereafter reduced to once daily.
Safety is assessed from adverse events reported by the patient and/or his parents or observed by the investigator at the site of application and elsewhere. The safety evaluation includes monitoring of routine haematology and serum chemistry parameters. Blood samples are analysed by local laboratories. Blood samples are taken to determine concentrations of tacrolimus.
Height, weight and pulse of the patient are recorded at each visit.
Efficacy is assessed by physician's global evaluation of clinical response, patient's parent/guardian's assessment of global response, physician's assessment of individual signs and the affected area assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has participated in the study FG-506-06-32, has applied at least one dose of study medication and has benefited from treatment in the opinion of the investigator.
- •Patient is likely to benefit from further treatment with tacrolimus ointment in the opinion of the investigator.
排除标准
- •Patient has a skin disorder on the affected (and to be treated) area, other than atopic dermatitis, requiring treatment.
- •Patient has clinically infected atopic dermatitis.
研究组 & 干预措施
1
干预措施: Tacrolimus Ointment 0.03% (Drug)
结局指标
主要结局
Assess safety from observations of adverse events, laboratory examinations, pulse, height, weight and tacrolimus blood concentrations
时间窗: 24 months
次要结局
- Assess efficacy from parameters as follows: - Physician's global evaluation of clinical response - Physician's assessment of individual signs - Affected area - Parent/guardian's assessment of global response - EASI(24 months)