NCT00691262已完成3 期
A Long Term, Non-comparative, Multi-centre Study to Further Evaluate the Response to Treatment and Safety of 0.03% Tacrolimus Ointment Administered in Pediatric Patients With Moderate to Severe Atopic Dermatitis.
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
- 166
- 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
Objective of this study is to further assess the response to treatment and safety of 0.03% tacrolimus (FK506) ointment when used for 6 months in pediatric patients with moderate to severe atopic dermatitis, known to be responsive to topical steroids.
详细描述
The main phase is 6 month duration, but the follow-up phase up to 12 months will allow the collection of RTT and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect AD 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
- 2 Years 至 15 Years（Child）
- 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 is aged 2 years to 15 years (not having completed his/her 16th birthday) 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's legal representative has given written informed consent. If the patient is capable of understanding the purposes and risks of the trial written informed consent has been obtained from the patient as well. 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 wash-out 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/patient and legal representative agree that the patient does not 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 before 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 (if before month 6) visit and at month 12/end of study (if after month 6) visit, each compared to baseline (day 1)(1 year)
研究者
相似试验
已完成
3 期
Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic DermatitisDermatitis, AtopicNCT00691145Astellas Pharma Inc350
Unknown
4 期
Efficacy and Safety of a Reduced Immunosuppression vs. Standard Triple Therapy in Senior Renal Transplant RecipientsImmunosuppression After Renal TransplantationNCT02453867Klemens Budde400
已完成
2 期
Tacrolimus Ointment Long Term Safety in Young Children With Atopic DermatitisDermatitis, AtopicNCT00560326Astellas Pharma Inc50
已完成
4 期
Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant RecipientsKidney TransplantNCT03749356Chong Kun Dang Pharmaceutical141
终止
4 期
A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis PatientsLupus NephritisNCT01316133Astellas Pharma Korea, Inc.37