Kaufmann 2004.
| Study characteristics | |
| Methods | Trial design: randomised, multicentre, parallel study Trial registration number: not reported Country: Germany Outpatient or hospital: 19 centres Date trial conducted: June 2001 to July 2002 Duration of trial participation: 4 weeks Inclusion criteria: · aged 3 to 23 months, with a diagnosis of AD · affecting 5% of the BSA ·a baseline IGA score of 2 (mild disease severity) or greater, based on the degree of erythema and infiltration/population Exclusion criteria: · Patients with insufficient washout periods i.e. one month or less for systemic corticosteroids and phototherapy, less than 2 weeks for antibiotics, and 1 week for topical steroids or other topical therapies that might have an effect on AD · immunocompromised patients, patients with other significant concomitant diseases or those with a known hypersensitivity to the study drug Additional design details: none |
| Participants | Total number randomised: 196 participants (130 to apply the intervention and 66 to apply the comparator) Mean age: intervention group 12.3 years (SD 6.1); comparator group 11.5 years (SD 5.8) Sex: intervention group 62.8% male, 37.2% female; comparator group 71.2% male and 28.8% female Ethnicity: intervention group: black 1.6%, Asian 5.4%, Caucasian 90.7%, other 2.3%; comparator group: black 0%, Asian 6.1%, Caucasian 92.4%, other 1.5% Duration of eczema: not reported Severity of eczema: intervention group, 9.3% mild, 58.1% moderate, 26.4% severe, 6.2% very severe; comparator group, 12.1% mild, 59.1% moderate, 25.8% severe, 3.0% very severe Body site: not reported Number of withdrawals: intervention group n = 13; comparator group n = 25. To quote: "the main reason for early discontinuation was lack of therapeutic effect in five patients (3.8%) in the pimecrolimus group and 23 patients (34.8%) in the vehicle group". Notes: none |
| Interventions | Run‐in details: patients with insufficient washout periods were excluded i.e. 1 month or less for systemic corticosteroids and phototherapy, less than 2 weeks for antibiotics, and 1 week for TCS or other topical therapies that might have an effect on AD Intervention: pimecrolimus 1% cream used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle cream used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator; emollients were only permitted on areas not treated with study medication. Notes: none |
| Outcomes | · Signs and symptoms using SCORAD · Treatment success using IGA and EASI · Quality of life using PQoL‐AD · Primary carers assessment of disease response, pruritus and sleep loss · Safety |
| Notes | Funding source: Novartis Pharma GmbH Declarations of interest: two authors reported grant research support from various pharmaceutical companies, including Novartis who developed pimecrolimus. Original language of publication: English Other: none |