OBJECTIVE: To explore the efficacy and safety of @entity5023 , cream and ointment, applied twice weekly in addition to maintenance treatment with emollients, in reducing the risk of relapse of chronic recurrent @entity483 . DESIGN: Randomised, double blind, parallel group study of 20 weeks' duration. SETTING: Dermatology outpatient clinics (6 countries, 39 centres). @entity1 : Adult (aged 12-65) @entity1 with moderate to severe @entity483 who were experiencing a flare. METHODS: @entity1 applied @entity5023 (0.05% cream or 0.005% ointment; once or twice daily) regularly for four weeks to stabilise their condition. The @entity1 whose disease was brought under control then continued into a 16 week maintenance phase, applying emollient on a daily basis with a bath oil as needed and either the same formulation of @entity5023 or its placebo base (emollient alone) twice weekly to the areas that were usually affected. MAIN OUTCOME MEASURE: Time to relapse of @entity483 during maintenance phase. RESULTS: 376 @entity1 entered the stabilisation phase, and 295 continued into the maintenance phase. After 16 weeks in the maintenance phase, the disease remained under control in 133 @entity1 (87 using @entity5023 twice weekly, 46 using emollient alone), 135 (40 @entity5023 , 95 emollient) had experienced a relapse, and 27 had discontinued. Median time to relapse was six weeks for emollient alone compared with more than 16 weeks for additional @entity5023 . @entity1 who applied @entity5023 cream twice weekly were 5.8 times less likely (95% confidence interval 3.1 to 10.8, P < 0.001) and @entity1 using @entity5023 ointment 1.9 times less likely (1.2 to 3.2, P=0.010) to have a relapse than @entity1 applying emollient alone. The groups showed no differences in adverse events. CONCLUSION: After @entity483 had been stabilised the addition of @entity5023 twice weekly to maintenance treatment with emollients significantly reduced the risk of relapse.

Twice weekly XXXX added to emollient maintenance treatment to reduce risk of relapse in @entity483 : randomised, double blind, parallel group study.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'Participants', 'PARTICIPANTS'] @entity483 :: ('MESH:D003876', 'Disease') :: ['atopic dermatitis'] @entity5023 :: ('MESH:C065382', 'Chemical') :: ['fluticasone propionate']
@entity5023 :: (MESH:C065382,Chemical) :: ['fluticasone propionate']
