Optimization of placebo use in clinical trials with systemic treatments for atopic dermatitis: an International Eczema Council survey-based position statement

J Eur Acad Dermatol Venereol. 2019 May;33(5):807-815. doi: 10.1111/jdv.15480. Epub 2019 Mar 12.


Background: As novel systemic therapeutics for patients with atopic dermatitis (AD) are developed, ethical and methodological concerns regarding placebo-controlled-trials (PCT) have surfaced.

Objective: To guide the design and implementation of PCT in AD, focusing on trials with systemic medications.

Methods: A subgroup of the International Eczema Council (IEC) developed a consensus e-survey, which was disseminated to IEC members.

Results: The response rate was 43/82 (52%). Consensus was reached on 24/27 statements and on 3/11 options from multiple-selection statements, including: performing monotherapy studies in proof-of-concept phases; avoiding concomitant topical corticosteroids or calcineurin inhibitors until a predefined timepoint as rescue (borderline consensus); selection of sites and assessors with recognized expertise in AD clinical trials; clear definition and identification of baseline disease severity; minimizing time and proportion of patients on placebo; using daily emollients with several options provided; instigating open-label extension studies for enrolment after a predefined timepoint; and including outcomes which set a higher bar for disease clearance.

Conclusion: Conducting PCT in AD requires balancing several, sometimes opposing principles, including ethics, methodology, regulatory requirements and real-world needs. This paper can provide a framework for conducting PCT with systemic medications for patients with AD.

MeSH terms

  • Clinical Trials as Topic*
  • Dermatitis, Atopic / drug therapy*
  • Dermatologic Agents / therapeutic use*
  • Humans
  • Placebos*
  • Surveys and Questionnaires


  • Dermatologic Agents
  • Placebos