Differences in pediatric versus adult clinical trial characteristics for atopic dermatitis

Background: Atopic dermatitis (AD) is a growing burden in all ages. The aim of this study was to compare trial characteristics between pediatric and adult AD trials. Methods: Data were collected from ClinicalTrials.gov on AD therapeutic trials completed between 2003 and 2019. The trials were classified as pediatrics (mean or median age <18 years of the experimental group participants) or adults. The trials with and without results on ClinicalTrials.gov were searched on PubMed for further data collection. Results: Of 210 trials, 50 (24%) were pediatric trials [mean age: 8.2 ± 4.3 years (SD)] and 160 (76%) were adult trials [mean age 35.2 ± 5.7 years (SD)]. Pediatric and adult trials were equally likely to be randomized controlled trials; however, pediatric trials were more likely to be open-label trials (P <.001) and have no comparator (P <.001). Adult trials were more likely to be industry-funded (95% vs. 80%, P =.001). Any evaluation of drug safety was more likely present in adult trials (83% vs. 60%, P =.001). In trials examining AD severity as an outcome, the Eczema Area and Severity Index (EASI) predominated in adult trials (51% vs. 29%, P <.05) and Scoring Atopic Dermatitis (SCORAD) in pediatric trials (25% vs. 10%, P <.05). Conclusion: The results highlight differences in trial design between pediatric and adult AD trials and show a lack of standardization in trial design.