Format

Send to

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

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

Author information

1
Department of Dermatology, Beilinson Hospital, Rabin Medical Center, Petach-Tikva, Israel.
2
Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
3
Innovaderm Research Inc, Montreal, QC, Canada.
4
Paul Sabatier University, Toulouse, France.
5
Department of Dermatology, Department of Preventive Medicine, and Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
6
Pediatric Dermatology, Our Lady's Children's Hospital Crumlin, Dublin, Ireland.
7
National Children's Research Centre, Our Lady's Children's Hospital Crumlin, Dublin, Ireland.
8
Clinical Medicine, Trinity College Dublin, Dublin, Ireland.
9
Departments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine and Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.
10
Sheffield Dermatology Research Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield, Sheffield, UK.
11
Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Abstract

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.

Supplemental Content

Full text links

Icon for Wiley Icon for PubMed Central
Loading ...
Support Center