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Differences in pediatric versus adult clinical trial characteristics for atopic dermatitis

Gaurav Agnihotri1, Peter A Lio2,3, Kachiu C Lee4

  • 1College of Medicine, University of Illinois at Chicago, Chicago, IL, USA.

Pediatric Dermatology
|June 26, 2021
PubMed

Insights

Pediatric atopic dermatitis (AD) trials are more likely open-label with no comparator, unlike adult AD trials. This highlights significant differences and a lack of standardization in clinical trial design for AD across age groups.

Area of Science:

  • Dermatology
  • Clinical Trial Design
  • Pediatric Research

Background:

  • Atopic dermatitis (AD) presents a growing health burden across all age demographics.
  • Understanding differences in clinical trial characteristics is crucial for advancing AD treatment research.

Purpose of the Study:

  • To compare the distinct characteristics of clinical trials conducted for pediatric atopic dermatitis versus adult atopic dermatitis.
  • Identify variations in trial design, methodology, and outcomes between pediatric and adult AD studies.

Main Methods:

  • A systematic review of atopic dermatitis (AD) therapeutic trials completed between 2003 and 2019 was conducted using ClinicalTrials.gov.
  • Trials were categorized as pediatric (mean age <18 years) or adult, with data supplemented by PubMed searches for trials with and without reported results.

Main Results:

  • Out of 210 trials, 50 (24%) were pediatric and 160 (76%) were adult AD trials.
  • Pediatric trials were more frequently open-label and lacked comparators compared to adult trials.
  • Adult trials were more often industry-funded and included drug safety evaluations, utilizing Eczema Area and Severity Index (EASI) for severity assessment, while pediatric trials favored the Scoring Atopic Dermatitis (SCORAD) index.

Conclusions:

  • Significant differences exist in the design and conduct of clinical trials for pediatric versus adult atopic dermatitis.
  • The findings underscore a notable lack of standardization in clinical trial design for atopic dermatitis research.
Abstract

Keywords:
atopic dermatitiseczema

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