Krueger 2006.
| Study characteristics | |
| Methods | Trial design: randomised, parallel study Trial registration number: not reported Country: USA and Mexico Outpatient or hospital: 8 centres Date trial conducted: not reported Duration of trial participation: 12 weeks Inclusion criteria: · Adults with moderate‐to‐severe AD according to Hanifin and Rajka and Rajka and Langeland criteria and of at least 3 months duration · Affecting 35% to 75% of BSA not including scalp Exclusion criteria: · Severe defective epidermal barrier function · Any other skin disorder · Clinically infected AD · Used systematic immunosuppressants or immunomodulators within 2 weeks prior · Topical or systematic steroids or topical immunomodulators within one week prior Additional design details: none |
| Participants | Total number randomised: 40 participants (19 to apply the intervention and 21 to apply the comparator) Age: intervention group, mean 42.5 years SD 17.0, range 17‐74; in tacrolimus 0.1% comparator group, mean 39.6 years SD 14.5, range 18‐69 years Sex: intervention group, female 68.4%, male 31.6%; comparator group, female 66.7%, male 33.3% Ethnicity: intervention group, black 21.1%, Asian 0, white 73.7% and other 5.3%; comparator group, black 19%, Asian 9.5%, white 61.9%, other 9.5% Duration of eczema: not reported Severity of eczema: intervention group, 26.3% moderate, 73.7% severe; comparator group, 33.3% moderate, 66.7% severe Body site: not reported Number of withdrawals: 11 withdrew Notes: none |
| Interventions | Run‐in details: the use of any form of tacrolimus or pimercrolimus was prohibited for 2 weeks prior. Intervention: tacrolimus 0.03% ointment used twice daily for 84 days · Concurrent treatment: not reported · Other key information: none Comparator: tacrolimus 0.1% ointment used twice daily for 84 days. · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
| Outcomes | · BSA · Withdrawals due to AE |
| Notes | Funding source: authors affiliated to Astellas Pharma Declarations of interest: not declared Original language of publication: English Other: none |