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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Unnamed facility
Beijing, China
Unnamed facility
Chongqing, China
Unnamed facility
Guangzhou, China
Unnamed facility
Shanghai, China
Time to first DE (disease exacerbation)
Time frame: 6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)
Number of DEs during the DCP
Time frame: 6 months of DCP (Disease Control Period)
Eczema Area and Severity Index (EASI)
Time frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Investigator's Global Assessment (IGA)
Time frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Duration of DE during DCP
Time frame: 6 months of DCP (Disease Control Period)
The overall efficacy during OLP
Time frame: After 2 to 6 weeks of OLP (Open Label Period)
Quantity of tacrolimus ointment used
Time frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Incidence of adverse events
Time frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
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