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Expert Perspectives on Key Parameters that Impact Interpretation of Randomized Clinical Trials in Moderate-to-Severe
Jonathan I Silverberg1, Eric L Simpson2, April W Armstrong3
1Department of Dermatology, The George Washington School of Medicine and Health Sciences, 2150 Pennsylvania Ave, NW, Suite 2B-430, Washington, DC, 30037, USA. jonathanisilverberg@gmail.com.
Abstract:
The recent advent of numerous clinical trials for the treatment of moderate-to-severe atopic dermatitis has led to new and emerging therapeutic options for this chronic inflammatory skin disease. With this rapid development has come a lack of consistency in study designs, trial conduct, and statistical analyses. Healthcare providers are challenged to interpret how variations in study parameters may influence clinical trial results. Based on literature review and our experience as clinical trialists, we compiled a list of 22 key study parameters of contemporary clinical trials in moderate-to-severe atopic dermatitis and ranked the top study parameters that may have a significant effect on efficacy results. The top parameters included study comparators, rules for rescue treatment, washout periods for topical and systemic treatments, inclusion criteria such as disease severity by Eczema Area and Severity Index and/or Investigator Global Assessment scores, and the duration of the screening period. We describe considerations for these key parameters, with a focus on between-parameter interactions and effect on efficacy results. This may serve to inform the interpretation of atopic dermatitis clinical trials and raise the profile of the need to harmonize the clinical trial design.
Insights
New clinical trials for atopic dermatitis treatments show inconsistent designs. Key parameters like comparators and inclusion criteria significantly impact efficacy results, necessitating harmonization for clearer interpretation.
Area of Science:
- Dermatology
- Clinical Trials
- Pharmacology
Background:
- Numerous clinical trials are evaluating new treatments for moderate-to-severe atopic dermatitis.
- Rapid development has resulted in inconsistencies in study designs, conduct, and statistical analyses.
- Healthcare providers face challenges interpreting trial results due to variable study parameters.
Framework:
- Identified 22 key study parameters in contemporary atopic dermatitis trials.
- Ranked parameters most likely to significantly affect efficacy outcomes.
- Focused on interactions between parameters and their influence on results.
Implementation:
- Key parameters include study comparators, rescue treatment rules, and washout periods.
- Inclusion criteria, such as Eczema Area and Severity Index (EASI) and Investigator Global Assessment (IGA) scores, are critical.
- Screening period duration also impacts efficacy assessments.
Implications:
- Provides considerations for interpreting atopic dermatitis clinical trial data.
- Highlights the need for harmonizing clinical trial design to improve consistency.
- Aims to enhance the understanding of how study variations affect treatment efficacy.
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