Systematic Review of Diagnostic Criteria Used in Atopic Dermatitis Randomized Controlled Trials

Background Numerous diagnostic criteria for atopic dermatitis are used in clinical trials, which may limit comparison of results. Objective We sought to determine the most commonly used atopic dermatitis diagnostic criteria in randomized controlled trials internationally. Methods We performed a systematic review of randomized controlled trials with a pharmacological intervention from 2007 to 2016. Cochrane Library, EMBASE, GREAT, LILACS, MEDLINE, and Scopus were searched. Two authors independently performed the study selection and data extraction. Results Two hundred and twelve randomized controlled trials met inclusion/exclusion criteria. Overall, ten different diagnostic criteria were used. The Hanifin and Rajka criteria were most commonly used (41.0%), followed by the UK refinement of the Hanifin and Rajka criteria (9.0%), Japanese Dermatological Association criteria (4.2%), and American Academy of Dermatology criteria (3.8%). No diagnostic criteria were specified in 37.3% of randomized controlled trials. The Hanifin and Rajka criteria were the most commonly used atopic dermatitis diagnostic criteria in clinical trials of topical and systemic interventions, across all years between 2007 and 2016, in pediatric and adult populations, in most countries and regions internationally. Conclusions The results highlight the lack of uniformity and documentation of atopic dermatitis diagnostic criteria in randomized controlled trials for atopic dermatitis. We recommend harmonizing the diagnostic criteria for atopic dermatitis in future randomized controlled trials.