Effectiveness and safety of a prevention-of-flare-progression strategy with pimecrolimus cream 1% in the management of paediatric atopic dermatitis
Autor: | B, Sigurgeirsson, V, Ho, C, Ferrándiz, K, Andriano, A, Grinienko, P, Jimenez, H, Velander |
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Rok vydání: | 2008 |
Předmět: |
medicine.medical_specialty
Randomization Adolescent medicine.drug_class Administration Topical Dermatology Tacrolimus law.invention Dermatitis Atopic Pimecrolimus Randomized controlled trial Double-Blind Method law medicine Humans skin and connective tissue diseases Child End point business.industry Atopic dermatitis medicine.disease Infectious Diseases Treatment Outcome Topical corticosteroid Multicenter study Child Preschool Disease Progression Corticosteroid Dermatologic Agents business medicine.drug |
Zdroj: | Journal of the European Academy of Dermatology and Venereology : JEADV. 22(11) |
ISSN: | 1468-3083 |
Popis: | Objective This study was performed to investigate the efficacy and safety of a prevention-of-flare-progression strategy with pimecrolimus cream 1% in children and adolescents with atopic dermatitis (AD). Methods A 26-week multi-centre, randomized, double-blind, vehicle-controlled study was conducted in 521 patients aged 2–17 years, with a history of mild or moderate AD, who were clear/almost clear of disease before randomization to pimecrolimus cream 1% (n = 256) or vehicle cream (n = 265). Twice-daily treatment with study medication was started at the first signs and/or symptoms of recurring AD. If, despite the application of study medication for at least 3 days, AD worsened (as confirmed by the investigator), treatment with a moderately potent topical corticosteroid (TCS) was allowed in both groups. The primary efficacy end point was the number of days on study without TCS use for a flare. Results The mean number of TCS-free days was significantly higher (P < 0.0001) in the pimecrolimus cream 1% group (160.2 days) than in the control group (137.7 days). On average, patients on pimecrolimus cream 1% experienced 50% fewer flares requiring TCSs (0.84) than patients on vehicle cream (1.68) (P |
Databáze: | OpenAIRE |
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