Consensus on core domains for hand eczema trials: Signs, symptoms, control and quality of life

Henriette Rönsch¹, Karl Philipp Drewitz², Amber Reck Atwater^{3

4}, Detlef Becker⁵, Philipp Bentz⁶, Richard Brans^{7

8}, Tricia Chong⁹, Heinrich Dickel¹⁰, Peter Elsner¹¹, Ana M Giménez-Arnau¹², Fabrizio Guarneri¹³, María Graciela Guzmán Perera¹⁴, Sarah Ibrahim¹⁵, Dimitra Koumaki¹⁶, Jamie Koelbel¹, Francesca Larese Filon¹⁷, Suzana Ljubojević Hadžavdić¹⁸, Laura Loman¹⁹, Mihaly Matura^{20

21}, Sonja Molin^{22

23}, Robert Ofenloch⁶, Katharina Piontek², Radoslaw Spiewak²⁴, Anne Strunk¹, Margo Reeder¹⁵, David Reissig^{1

25}, Thomas Rustemeyer²⁶, Marie-Louise Schuttelaar¹⁹, Dagmar Simon²⁷, Manon Sloot¹⁹, Markus F C Steiner²⁸, Saïda Tongalaza², Skaidra Valiukevičienė²⁹, Maurice Waitek⁶, Elke Weisshaar⁶, Stefan Wöhrl³⁰, Doreen Wolff², Andrea Bauer¹, Christian Apfelbacher²

Affiliations

¹ Department of Dermatology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
² Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto von Guericke University, Magdeburg, Germany.
³ Department of Dermatology, George Washington University, Washington, DC, USA.
⁴ Distinctive Dermatology, Vienna, Virginia, USA.
⁵ Department of Dermatology, University of Mainz, Mainz, Germany.
⁶ Division of Occupational Dermatology, Department of Dermatology, Ruprecht-Karls-University, Heidelberg, Germany.
⁷ Department of Dermatology, Environmental Medicine and Health Theory, Osnabrück University, Osnabrück, Germany.
⁸ Institute for Interdisciplinary Dermatologic Prevention and Rehabilitation (iDerm), Osnabrück University, Osnabrück, Germany.
⁹ National Skin Centre, Singapore, Singapore.
¹⁰ Department of Dermatology, Venereology and Allergology, St. Josef Hospital, University Medical Center, Ruhr University Bochum, Bochum, Germany.
¹¹ SRH Hospital Gera, Gera, Germany.
¹² Department of Dermatology, Hospital del Mar Research Institute, Universitat Pompeu Fabra, Barcelona, Spain.
¹³ Dermatology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
¹⁴ Dermatology Department, Hospital Angeles del Pedregal, Mexico City, Mexico.
¹⁵ Department of Dermatology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
¹⁶ Dermatology Department, University Hospital of Heraklion, Heraklion, Crete, Greece.
¹⁷ Clinical Unit of Occupational Medicine, University of Trieste, Trieste, Italy.
¹⁸ Department of Dermatology and Venereology, University Hospital Center Zagreb, School of Medicine University of Zagreb, Zagreb, Croatia.
¹⁹ Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
²⁰ Departments of Dermatology, Norrlands University Hospital, Umeå, Sweden.
²¹ Örebro University Hospital, Örebro, Sweden.
²² Division of Dermatology, Queen's University, Kingston, Ontario, Canada.
²³ Department of Dermatology, Venerology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
²⁴ Department of Experimental Dermatology and Cosmetology, Jagiellonian University Medical College, Krakow, Poland.
²⁵ Institute and Policlinic of Occupational and Social Medicine, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany.
²⁶ Department of Dermatology, Allergology and Occupational Dermatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
²⁷ Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
²⁸ NHS Grampian, Occupational Health Service, Aberdeen, UK.
²⁹ Department of Skin and Venereal Diseases, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.
³⁰ Floridsdorf Allergy Center (FAZ), Vienna, Austria.

PMID: 40276953
PMCID: PMC12376261
DOI: 10.1111/jdv.20671

Consensus on core domains for hand eczema trials: Signs, symptoms, control and quality of life

Henriette Rönsch et al. J Eur Acad Dermatol Venereol. 2025 Sep.

. 2025 Sep;39(9):1588-1599.

doi: 10.1111/jdv.20671. Epub 2025 Apr 25.

Authors

Affiliations

¹ Department of Dermatology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
² Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto von Guericke University, Magdeburg, Germany.
³ Department of Dermatology, George Washington University, Washington, DC, USA.
⁴ Distinctive Dermatology, Vienna, Virginia, USA.
⁵ Department of Dermatology, University of Mainz, Mainz, Germany.
⁶ Division of Occupational Dermatology, Department of Dermatology, Ruprecht-Karls-University, Heidelberg, Germany.
⁷ Department of Dermatology, Environmental Medicine and Health Theory, Osnabrück University, Osnabrück, Germany.
⁸ Institute for Interdisciplinary Dermatologic Prevention and Rehabilitation (iDerm), Osnabrück University, Osnabrück, Germany.
⁹ National Skin Centre, Singapore, Singapore.
¹⁰ Department of Dermatology, Venereology and Allergology, St. Josef Hospital, University Medical Center, Ruhr University Bochum, Bochum, Germany.
¹¹ SRH Hospital Gera, Gera, Germany.
¹² Department of Dermatology, Hospital del Mar Research Institute, Universitat Pompeu Fabra, Barcelona, Spain.
¹³ Dermatology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
¹⁴ Dermatology Department, Hospital Angeles del Pedregal, Mexico City, Mexico.
¹⁵ Department of Dermatology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
¹⁶ Dermatology Department, University Hospital of Heraklion, Heraklion, Crete, Greece.
¹⁷ Clinical Unit of Occupational Medicine, University of Trieste, Trieste, Italy.
¹⁸ Department of Dermatology and Venereology, University Hospital Center Zagreb, School of Medicine University of Zagreb, Zagreb, Croatia.
¹⁹ Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
²⁰ Departments of Dermatology, Norrlands University Hospital, Umeå, Sweden.
²¹ Örebro University Hospital, Örebro, Sweden.
²² Division of Dermatology, Queen's University, Kingston, Ontario, Canada.
²³ Department of Dermatology, Venerology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
²⁴ Department of Experimental Dermatology and Cosmetology, Jagiellonian University Medical College, Krakow, Poland.
²⁵ Institute and Policlinic of Occupational and Social Medicine, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany.
²⁶ Department of Dermatology, Allergology and Occupational Dermatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
²⁷ Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
²⁸ NHS Grampian, Occupational Health Service, Aberdeen, UK.
²⁹ Department of Skin and Venereal Diseases, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.
³⁰ Floridsdorf Allergy Center (FAZ), Vienna, Austria.

PMID: 40276953
PMCID: PMC12376261
DOI: 10.1111/jdv.20671

Abstract

Background: Hand eczema (HE) is a common and complex skin disease. A uniform set of core outcomes and related measures for use in clinical trials is lacking, making it difficult to compare results across HE studies.

Objective: To reach consensus on a set of core domains and subdomains that should be measured in future therapeutic HE trials.

Methods: In 2024, we conducted a two-round online Delphi (eDelphi) survey among international HE experts, including physicians, patients and their relatives, researchers and industry representatives. A domain/subdomain was included in the core set when ≥80% of participants rated is as 'critically important'; 50% agreement or less resulted in its exclusion. Results from 50% to 80% were deemed controversial and subject for further discussion. During a hybrid consensus meeting, the stakeholders reviewed, completed and, if necessary, revised the preliminary eDelphi consensus.

Results: In the first and second round of the eDelphi, 208 and 134 persons, respectively, participated. Forty participants from 18 countries attended the consensus meeting. Consensus was reached to include the core domains 'signs of HE' (with five core subdomains), 'symptoms of HE' (two subdomains), 'HE-related quality of life' (four subdomains) and 'HE control over time' (four subdomains). The subdomains 'desquamation/scaling' and 'emotional impact/mental health' remained controversial. Consensus was reached that the domains 'skin barrier function' and 'patient-reported treatment experience' and 28 subdomains should not be part of the core outcome set.

Conclusions: To produce comparable and meaningful results, future trials evaluating the effectiveness of HE treatments should measure signs and symptoms of HE, HE-related quality of life and HE control over time as core outcome domains. The next step of the HE core outcome set initiative (HECOS) is to identify appropriate measurement instruments.

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Conflict of interest statement

Christian Apfelbacher was involved in the development and validation of the Quality Of Life in Hand Eczema Questionnaire (QOLHEQ). He has received honoraria for consultancy work from Dr. Wolff GmbH Bionorica, Sanofi, LEO Pharma, Incyte, Pfizer, Rheacell and IVDK and institutional funding from Dr. Wolff GmbH and Bionorica. Andrea Bauer is involved in clinical trials on hand eczema (LEO Pharma, Bristol Myers Squibb); she has been a speaker/advisor/investigator and/or received research funding from AbbVie, Almirall, Lilly, Galderma, Incyte, Janssen, LEO Pharma, L'Oréal, Pfizer, Regeneron and Sanofi. Richard Brans served as advisory board member and speaker for LEO Pharma. Detlef Becker received speaking honoraria from Sanofi‐Aventis. Heinrich Dickel has received honoraria as an advisory board member and/or speaker from Almirall Hermal GmbH, Stallergenes GmbH, LEO Pharma GmbH and Novartis Pharma GmbH. KP Drewitz is employed part‐time by Information Network of Departments of Dermatology, which is partly sponsored by Smart Practice Europe, the cosmetic industry or associations. Peter Elsner has been a speaker/advisor/investigator and/or received research funding from Almirall, Bayer, LEO Pharma, L'Oréal, Pierre Fabre, Sanofi and UCB. Ana M Gimenez‐Arnau is or recently was a speaker and/or advisor for and/or has received research funding from Almirall, Amgen, AstraZeneca, Avene, Blue‐ Print, Celldex, Escient Pharmaceutials, Genentech, GSK, Harmonic Bio, Instituto Carlos III‐ FEDER, Jaspers, Leo Pharma, Menarini, Mitsubishi Tanabe Pharma, Noucor, Novartis, Sanofi–Regeneron, Septerna, Servier, Thermo Fisher Scientific, Uriach Pharma. Fabrizio Guarneri has served as advisory board member for Leo Pharma. Francesca Larese Filon received a grant for 2 years' post‐doc from Unifarco–Santa Giustina–Belluno (Italy). Suzana Ljubojević Hadžavdić is PI for atopic dermatitis Clinical Study (Abbvie, Amgen, Nektar) and was PI for chronic spontaneous urticaria Clinical study (Novartis). She was lecturer for Novartis, Abbvie, Sanofi, Pliva, Bayer and Berlin‐Chemi. Sonja Molin has received honoraria as consultant/advisor or speaker and/or grants from Abbvie, Almirall, Aralez, Arcutis, Basilea, Bausch and Lomb, Bristol Myer Squibb, Boehringer‐Ingelheim, Evidera, Galderma, GSK, Incyte, Jamp Biopharma, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi, Sun Pharma and UCB. Robert Ofenloch was involved in the development and validation of the QOLHEQ. Marie L.A. Schuttelaar was involved in the validation of the QOLHEQ, and is an advisor, consultant, speaker and/or investigator for Sanofi Genzyme, Regeneron Pharmaceuticals, Amgen, Incyte, Pfizer, Abbvie, LEO Pharma and Galderma. Dagmar Simon has been an investigator, advisory board member, or consultant for: AbbVie, Almirall, Amgen, AstraZeneca, Galderma, Incyte, LEO, Eli Lilly, Novartis, Pfizer and Sanofi Genzyme. Radoslaw Spiewak is a part‐time employee and shareholder at the Instytut Dermatologii, Krakow, Poland. He received lecture honoraria from the Polish Society of Allergology, the Polish Dermatological Society and Chiesi. His department received funds from Jagiellonian University Medical College, Krakow, Poland. Elke Weisshaar was involved in the development and validation of the QOLHEQ. The other authors have no conflicts of interest.

Figures

**FIGURE 1**
Course of the consensus meeting, LG: large group session; SG: small group discussion.

**FIGURE 2**
Country of residence of eDelphi participants.

**FIGURE 3**
Experience with hand eczema of eDelphi participants.

**FIGURE 4**
Core outcome domains and subdomains for therapeutic hand eczema trials.

See this image and copyright information in PMC

References

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Consensus on core domains for hand eczema trials: Signs, symptoms, control and quality of life

Affiliations

Consensus on core domains for hand eczema trials: Signs, symptoms, control and quality of life

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical