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Acute and maintenance treatment of atopic dermatitis in children - two comparative studies with fluticasone propionate (0.05%) cream.

Author(s): Kirkup ME, Birchall NM, Weinberg EG, Helm K, Kennedy CT

Affiliation(s): Bristol Royal Infirmary and Bristol Royal Hospital for Sick Children, Bristol, UK. Maggie.Kirkup@ubht.swest.nhs.uk

Publication date & source: 2003-09, J Dermatolog Treat., 14(3):141-8.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

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.

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