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Differences in pediatric versus adult clinical trial characteristics for atopic dermatitis
Author(s) -
Agnihotri Gaurav,
Lio Peter A.,
Lee Kachiu C.
Publication year - 2021
Publication title -
pediatric dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.542
H-Index - 73
eISSN - 1525-1470
pISSN - 0736-8046
DOI - 10.1111/pde.14658
Subject(s) - medicine , clinical trial , scorad , atopic dermatitis , randomized controlled trial , pediatrics , disease , dermatology , dermatology life quality index
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.