BACKGROUND: Two multicentre, randomised, parallel group, double-blind, comparative studies in children (2-14 yr) evaluatedfluticasone propionate (FP) 0.05% cream for both acute and maintenance treatment of moderate to severe atopic dermatitis (AD). METHODS: One study compared FP with hydrocortisone (HC) 1% cream (FP 70, HC 67) and the other with hydrocortisone butyrate (HCB) 0.1% cream (FP 67, HCB 62). Treatments were applied twice daily, for 2-4 weeks until the AD was stabilised, and thereafter intermittently ('as required') for up to 12 weeks. RESULTS: The primary outcome measure, Total AD Score, recorded at the end of the acute and maintenance phases, was significantly lower (indicating improvements in disease severity) following treatment with FP compared with either HC or HCB (acute phase difference vs. HC, -2.39, 95%CI -3.47, -1.31; p<0.001 and vs. HCB, -1.25, 95%CI -2.46, -0.05; p=0.042) and (maintenance phase difference vs. HC, -1.88, 95%CI -3.20, -0.56; p=0.006 and vs. HCB, -1.39, 95%CI -2.72, -0.05; p=0.042). In both studies treatments were equally well tolerated with no visible signs of skin atrophy. CONCLUSION: In both the acute and longer term management of AD in children, FP demonstrated a high level of efficacy and maintenance of disease control with a tolerability similar to HC 1%, a lower potency corticosteroid.
RCT Entities:
BACKGROUND: Two multicentre, randomised, parallel group, double-blind, comparative studies in children (2-14 yr) evaluated fluticasone propionate (FP) 0.05% cream for both acute and maintenance treatment of moderate to severe atopic dermatitis (AD). METHODS: One study compared FP with hydrocortisone (HC) 1% cream (FP 70, HC 67) and the other with hydrocortisone butyrate (HCB) 0.1% cream (FP 67, HCB 62). Treatments were applied twice daily, for 2-4 weeks until the AD was stabilised, and thereafter intermittently ('as required') for up to 12 weeks. RESULTS: The primary outcome measure, Total AD Score, recorded at the end of the acute and maintenance phases, was significantly lower (indicating improvements in disease severity) following treatment with FP compared with either HC or HCB (acute phase difference vs. HC, -2.39, 95%CI -3.47, -1.31; p<0.001 and vs. HCB, -1.25, 95%CI -2.46, -0.05; p=0.042) and (maintenance phase difference vs. HC, -1.88, 95%CI -3.20, -0.56; p=0.006 and vs. HCB, -1.39, 95%CI -2.72, -0.05; p=0.042). In both studies treatments were equally well tolerated with no visible signs of skin atrophy. CONCLUSION: In both the acute and longer term management of AD in children, FP demonstrated a high level of efficacy and maintenance of disease control with a tolerability similar to HC 1%, a lower potency corticosteroid.
Authors: Stephanie J Lax; Jane Harvey; Emma Axon; Laura Howells; Miriam Santer; Matthew J Ridd; Sandra Lawton; Sinéad Langan; Amanda Roberts; Amina Ahmed; Ingrid Muller; Long Chiau Ming; Saumya Panda; Pavel Chernyshov; Ben Carter; Hywel C Williams; Kim S Thomas; Joanne R Chalmers Journal: Cochrane Database Syst Rev Date: 2022-03-11
Authors: Karlijn F van Halewijn; Arthur M Bohnen; Pieter J van den Berg; Suzanne G M A Pasmans; Patrick J E Bindels; Gijs Elshout Journal: BMJ Open Date: 2019-06-19 Impact factor: 2.692