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To assess if proactive, 2 times-weekly application of 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.
This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continued tacrolimus treatment | Experimental | children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period. |
|
| no additional treatment | No Intervention | children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first DE (disease exacerbation) | 6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of DEs during the DCP | 6 months of DCP (Disease Control Period) | |
| Eczema Area and Severity Index (EASI) | 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Investigator's Global Assessment (IGA) | 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) |
| Duration of DE during DCP | 6 months of DCP (Disease Control Period) |
| The overall efficacy during OLP | After 2 to 6 weeks of OLP (Open Label Period) |
| Quantity of tacrolimus ointment used | 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) |
| Incidence of adverse events | 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) |
| Chongqing |
| China |
| Guangzhou | China |
| Shanghai | China |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |