Spergel 2007.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, multicentre, within‐patient study Trial registration number: NCT00119158 Country: US Outpatient or hospital: four academic centres Date trial conducted: October 2004 to June 2005 Duration of trial participation: 2 weeks Inclusion criteria: · Age 2 to 65 years · AD according to the American Academy of Dermatology Consensus Conference (2001) · At least two lesions of AD on symmetrical part of the body (same location for each side of the body), of severe intensity (m‐EASI is at least 7 on each site, with erythema of at least 3 (severe) and papulation/infiltration of at least 3 (severe)) and similar severity (m‐EASI does not differ from more than 2 points on both sides) · Female is able to enter and participate in this study if she is of: Non‐childbearing potential or childbearing potential, has a negative pregnancy test (urine) at the screen visit and agrees to an adequate method of birth control throughout the study (which may, at the investigator's discretion, include abstinence) Exclusion criteria: · Active skin infection or other skin disorders · History of immune deficiencies or history of malignant disease · Patients with moderate‐to‐severe lichenification at the target areas (i.e. score 2 or 3) · Active cutaneous bacterial, viral or fungal infections Additional design details: none |
| Participants | Total number randomised: 94 sides treated (47 to apply the intervention and 47 to apply the comparator) Age: 2 to 65 years Sex: male n = 18 Ethnicity, duration of eczema: not reported Severity of eczema: severe Body site: extremities Number of withdrawals: two participants were excluded from analysis: one patient used oral steroids for an acute exacerbation of asthma and the second participant was noncompliant with the treatment regimen. Notes: none |
| Interventions | Run‐in details: not reported Intervention: pimecrolimus 1% cream used once daily for 14 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle cream used once daily for 14 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: fluticasone propionate cream 0.05%. Participants had to stop topical medications 1 week and systemic therapies 4 weeks prior to the start of the study. During the study, concomitant topical or systemic therapies for AD were prohibited. Notes: none |
| Outcomes | · EASI · IGA · Patient assessed signs ‐ not reported |
| Notes | Funding source: Novartis Declarations of interest: not declared but author affiliation to Novartis Original language of publication: English Other: none |