The treatment of facial atopic dermatitis in children who are intolerant of, or dependent on, topical corticosteroids: a randomized, controlled clinical trial
| Autor: | Mizutani G, Guettner A, Peter H. Hoeger, Thomas Hultsch, J. Jautova, Johannes Wohlrab, Kwang Hoon Lee |
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| Rok vydání: | 2008 |
| Předmět: |
Male
medicine.medical_specialty Eczema Dermatology Eczema Area and Severity Index Severity of Illness Index Tacrolimus law.invention Dermatitis Atopic Pimecrolimus Randomized controlled trial Double-Blind Method law Adrenal Cortex Hormones NECK PRURITUS Medicine Humans Adverse effect Child business.industry Pruritus Atopic dermatitis medicine.disease Clinical trial Treatment Outcome Child Preschool Female Dermatologic Agents Pharmaceutical Vehicles business Facial Dermatoses Clearance medicine.drug |
| Zdroj: | The British journal of dermatology. 160(2) |
| ISSN: | 1365-2133 |
| Popis: | Summary Background Atopic dermatitis (AD) is most prevalent in areas of reduced skin barrier reserve, like face and neck, especially in children. Treatment with topical corticosteroids (TCS) is limited due to heightened risk of treatment-associated side-effects, thus necessitating alternative AD therapies. Objectives The primary study objective was to determine the efficacy of pimecrolimus cream 1% in children with mild–moderate facial AD dependent on/intolerant of TCS. Secondary objectives included effects on overall Eczema Area and Severity Index (EASI), head/neck EASI, pruritus severity and time to clearance of facial AD. Methods A multicentre, double-blind (DB) study of ≤ 6 weeks, followed by a 6-week, open-label (OL) phase was conducted. Two hundred patients (aged 2–11 years) were randomized 1 : 1 to pimecrolimus cream 1% (n = 99) or vehicle (n = 101) twice daily until clearance of facial AD or for a maximum of 6 weeks (DB phase). Sixteen patients receiving vehicle were allowed to switch to the OL phase at day 22. Results Significantly more pimecrolimus-treated vs. vehicle-treated patients were cleared/almost cleared of facial AD (Investigators’ Global Assessment 0/1): 74·5% vs. 51·0%, P |
| Databáze: | OpenAIRE |
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