Proactive treatment with 0.03% tacrolimus cream in children with moderate/severe dermatitis
- Conditions
- Atopic DermatitisMedDRA version: 17.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-001040-11-Outside-EU/EEA
- Lead Sponsor
- Astellas Pharma China, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria for period 1:
Diagnosed as AD according to Williams diagnostic criteria, and moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland
Patients of 2-15 years old, male or female;
Patient is able to reach the centre within 3 days in case of a disease exacerbation.
A signed informed consent by the patient’s legal representative, if the patient has ability to understand the purpose and risk of the study then a written consent by the patient will also be needed.
Inclusion Criteria for period 2:
Patients who have completed the Period 1 of the study; and
Patients with IGA =2 at the end of Period 1 of the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients with known allergy to tacrolimus ointment;
Patients with serious skin infections in AD skin lesions area;
Patients with serious liver and kidney disease, blood system disease, autoimmune disease, chronic severe infections, diabetes, mental illness, and abusing illegal drugs and alcohol sufficient;
Patients with malignant tumor or other serious disease which may affect the correct evaluation of efficacy;
Patients using local corticosteroids or other immunosuppressive drugs within 1 week, or withdraw time of systematic corticosteroids and other immunosuppressive drugs(cyclosporine, leigongteng, etc.) within 4 weeks;
Patients who participated previously in another clinical study within 1 month; and
Patients with other reasons for which the investigators consider they should not be enrolled.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess if proactive, 2 times-weekly application of 0.03% tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.;Secondary Objective: Not applicable;Primary end point(s): Time of first relapse<br>;Timepoint(s) of evaluation of this end point: From the end of Period 1 to the first relapse.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Number of relapse during Period 2;<br>Severity of AD when recurs in Period 2 (EASI and IGA);<br>Duration of relapse in Period 2;<br>Pruritus score (VAS) when relapse in Period 2;<br>Amount of usage of Tacrolimus in Period 2; and<br>Overall effective rate (EASI) in Period 1.<br>;Timepoint(s) of evaluation of this end point: Period 2; and Period 1 and 2 for EASI