Meurer 2010.

Study characteristics
Methods	Trial design: randomised, multicentre, parallel study Trial registration number: CASM981C2439 Country: US Outpatient or hospital: 65 centres: Italy n = 10, USA n = 15, South Africa n = 5, Canada n = 7, Germany n = 28 Date trial conducted: May 2005 to January 2007 Duration of trial participation: 4 weeks Inclusion criteria: · Aged 2 or above and under 17 years · Severe AD as defined by a whole body IGA score of 4.0 or greater · Disease affecting 5% or greater of the total BSA, excluding the face Exclusion criteria: patients with abnormal HPA‐axis function Additional design details: a 4‐week randomised treatment period was followed by a 12‐week observational period.
Participants	Total number randomised: 376 participants (193 to apply the intervention and 183 to apply the comparator) Age: mean 8.3 years (SD 4.61), age group less than 2 years n = 1, 2 to 12 years n = 287, 13 to 17 years n = 85, median 8 years (range 1 to 17) Sex: 50.7% male, 49.3% female Ethnicity: Asian 8.3%, black 9.4%, white 61.9%, Native American 1.1%, other 19%, Pacific Islander 0.3% Duration of eczema: not reported Severity of eczema: based on IGA, 81.8% had severe disease; 17.2% very severe Body site: not reported Number of withdrawals: 10, 5 in each group. Reasons: AE n = 1, lost to follow‐up n = 4, protocol violation n = 1, subject withdrew consent n = 2, unsatisfactory therapeutic effect n = 2 Notes: none
Interventions	Run‐in details: phototherapy and systemic therapies were prohibited for 4 weeks. Topical therapy with pimecrolimus, tacrolimus, tar or corticosteroids were also not allowed for 7 days. Intervention: pimecrolimus 1% cream combined with TCS used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle cream combined with TCS used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: fluticasone propionate 0.5% (or hydrocortisone acetate cream 1% for face, neck and intertriginous areas, if needed) Notes: none
Outcomes	· Incidence rates of AEs . Time to relapse of AD during the observation period . Time to AD treatment success . AD treatment success and improvement . Improvement in extent and severity of AD . Relief of pruritus (success defined as 0 = absent or 1 = mild) . Improvement in health‐related QoL over baseline (measured by the PIQoL‐AD for participants aged 2 to 12 years only)
Notes	Funding source: Novaritis Declarations of interest: authors affiliation to Novartis Original language of publication: English Other: none