A randomized, open-label, comparative study to evaluate an intermittent dosing regimen of fluticasone propionate 0.05% cream (twice per week) in reducing the risk of relapse when added to regular daily moisturization using PHYSIOGEL Lotion in paediatric subjects with stabilized atopic dermatitis

Trial description: This is an open-label, randomized, comparative study, including 4 phases: SCREENING, ACUTE, MAINTENANCE and FOLLOW-UP.Subjects will complete the SCREENING phase to check the eligibility within 7 days after they sign the written informed consent form. All eligible subjects will be enrolled in ACUTE phase to receive twice daily Fluticasone propionate (FP) 0.05% cream up to 4 weeks. The efficacy and safety in ACUTE phase will be assessed every 2 weeks up to 4 weeks or until Treatment Success which depends on which time point comes first. Then subject can get into the MAINTENANCE phase receiving either emollient twice daily plus FP 0.05% cream once daily twice a week (Group A), or emollient twice daily (Group B), by 1:1 randomization. The treatment duration in MAINTENANCE phase will be up to 20 weeks. The efficacy and safety in MAINTENANCE phase will be assessed every 4 weeks up to 20 weeks or until AD relapse that depends on which time point comes first. If subjects don’t experience relapse during MAINTENANCE phase, subsequent FOLLOW-UP phase applying emollient twice daily won’t be longer than another 12 weeks.Total study duration is up to 37 weeks. All subjects receive FP 0.05% cream twice daily up to 4 weeks to all affected sites and any newly occurring sites in ACUTE phase. After randomization in MAINTENANCE phase, subjects either receive emollient twice daily extendedly plus FP 0.05% cream once daily twice a week to all healed sites and any newly occurring sites (Group A), or emollient twice daily extendedly (Group B), up to 20 weeks. In FOLLOW-UP phase, all subjects apply emollient twice daily up to 12 weeks.This study will enrol 120 subjects, and propose at least 80 subjects to be randomized.Study Endpoints/Assessments:Primary endpoint is to observe the median time to the first relapse of AD during MAINTENANCE phase.Secondary endpoints are: 1) Median time to the first relapse of AD during the whole study (including maintenance phase and follow-up phase.2) Numbers of recurrent patients at the end of MAINTENANCE phase;3) Numbers of recurrent patients at the end of FOLLOW-UP phase; 4) The effective rates (proportion of “treatment success” patients) during ACUTE phase (V3, W-2±2days;V4, W0±2days )5) Evaluate the safety during the whole study duration (ACUTE phase, MAINTENANCE phase, FOLLOW-UP phase respectively); 6) Evaluate visual skin assessment for signs of cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation changes during the whole study duration (ACUTE phase, MAINTENANCE phase, FOLLOW-UP phase respectively);7) The change of Quality of Life (QoL) from baseline at the end of MAINTENANCE phase; 8) The change of Quality of Life (QoL) from baseline at the end of FOLLOW-UP phase;9) Subjects’ post-study evaluation to drugs.