Luger 2004.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, multicentre study Trial registration number: not reported Country: 35 centres in nine countries; Belgium, Canada, Denmark, Finland, France, Germany, The Netherlands, Norway and the UK Outpatient or hospital, date trial conducted: not reported Duration of trial participation: 1 year Inclusion criteria: · 18 to 79 years · AD of moderate‐to‐severe disease · Affecting at least 5% of the total BSA Exclusion criteria: · Treatment with phototherapy · Radiation therapy or systemic therapy for AD in the previous month · Treatment with topical therapy (other than tar shampoo on the scalp) not stopped 24 hours before first application of study medication · Malignancy Additional design details: not reported |
| Participants | Total number randomised: 658 participants (328 to apply the intervention and 330 to apply the comparator) Age: 18 to 79 years; intervention group, mean 33.4 years; comparator group, mean 33.5 years Sex: male/female; intervention group 146/182; comparator group 153/177 Ethnicity: intervention: Caucasian n = 294, black n = 6, oriental n = 16, other n = 7, missing n = 5; control: Caucasian n = 293, black n = 15, oriental n = 10, other n = 7, missing n = 5 Duration of eczema: not reported Severity of eczema: mild‐to‐severe (inclusion criteria stated moderate‐to‐severe but table of characteristics listed mild‐to‐severe) Body site: all Number of withdrawals: not reported Notes: none |
| Interventions | Run‐in details: not reported Intervention: pimecrolimus 1% cream used twice daily for 1 year · Concurrent treatment: not reported · Other key information: none Comparator: triamcinolone acetonide 0.1% cream used twice daily for 1 year · Concurrent treatment: 1% hydrocortisone acetate cream (for the face, neck and intertriginous areas) · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
| Outcomes | · Local AE · EASI · IGA |
| Notes | Funding source: Novartis Pharma AG Declarations of interest: not declared Original language of publication: English Other: none |