Hoeger 2009.

Study characteristics
Methods	Trial design: randomised, double‐blind, multicentre, parallel study Trial registration number: NCT00130364 Country: Germany, South Korea and Slovakia Outpatient or hospital: not reported Date trial conducted: August 2005 to August 2006 Duration of trial participation: 6 weeks Inclusion criteria: · Aged 2 to 11 years, with mild‐to‐moderate facial AD (based on the facial IGA at baseline) · Dependent on, or intolerant of, TCS. Intolerance to TCS was defined by either an allergic reaction preventing use of TCS, presence of perioral dermatitis, rosacea, telangiectasia and ⁄or skin atrophy known to have resulted from use of TCS, or eyelid dermatitis associated with raised intraocular pressure ⁄history of glaucoma. Dependence was defined as an unacceptable level of recent use of TCS on the head and neck that, based on the investigator’s judgement and patient’s medical history, may have resulted in AEs. Exclusion criteria: · AD on > 30% of total body surface area · Concurrent skin disease in the study area, active skin infections, or other conditions that might interfere with study evaluations · Immunocompromised patients or patients with a history of malignant disease · Previous treatment with topical pimecrolimus or tacrolimus where there was either poor clinical response or hypersensitivity resulted · Within 4 weeks prior to the start of the trial, had received phototherapy or systemic therapy known or suspected to have an effect on AD, or had received investigational drugs within 8 weeks of the first application of the study drug or planned use of other investigational drugs during the study Additional design details: additional 6 weeks follow‐up, but open‐label
Participants	Total number randomised: 200 participants (99 to apply the intervention and 101 to apply the vehicle) Age: 2 to 11 years old. The median age was 5 years in each group. Sex: overall: males 50.5%, females 49.5%; pimecrolimus group: males 43.4%, females 56.6%; vehicle group: males 57.4%, females 42.6% Ethnicity: white: 67%, Asian: 32% Duration of eczema: not reported Severity of eczema: mild‐to‐moderate facial atopic dermatitis. Patients were well‐matched for baseline IGA severity. Body site: facial atopic dermatitis, dependent on or intolerant of topical corticosteroids Number of withdrawals: 6 patients discontinued in the pimecrolimus group (3 for unsatisfactory therapeutic effect, 1 protocol deviation and 2 withdrawal of consent); 25 in the vehicle group (2 for AE, 17 unsatisfactory therapeutic effect, 1 protocol deviation, 3 withdrawal of consent, 2 lost to follow‐up) Notes: none
Interventions	Run‐in details: none Intervention: pimecrolimus 1% cream used twice daily for 42 days Concurrent treatment: not reported Other key information: none Comparator: vehicle cream used twice daily for 42 days Concurrent treatment: not reported Other key information: none Concurrent treatments received alongside both intervention and comparator: emollients Notes: patients stopped using the treatment early if they achieved a facial IGA of 0 (clear). Treatment was to be resumed upon recurrence of first signs and symptoms of atopic dermatitis. Treatment was applied to face, head and neck at the same time each day, 12 hours apart. For treatment of the rest of the body, the study medication was to be applied twice daily, intermittently, on an ‘as‐needed’ basis, i.e. to each affected area of the skin (excluding face, head and neck) until clearance occurred, when treatment stopped.
Outcomes	· Treatment success at day 43, as assessed by the facial IGA score (0/1 = clear/almost clear) · Overall EASI, head and neck EASI at day 43 · Pruritus severity score at day 43 · Time to clearance of facial atopic dermatitis (facial IGA score of 0/1) over 6 weeks · Effect on eyelid dermatitis · Amount of study drug used (by weight) · Safety and tolerability after 6 weeks treatment
Notes	Funding source: supported by a grant from Novartis Pharma AG Declarations of interest: four authors received research funds and ⁄or fees from Novartis as speakers. Three authors are employees of Novartis. Original language of publication: English Other: none