Study protocol: efficacy of oral alitretinoin versus oral cyclosporine A in patients with severe recurrent vesicular hand eczema (ALICsA): a randomised prospective open-label trial with blinded outcome assessment

BMJ Open
Jart Ate Franke Oosterhaven, Marie Louise Anna Schuttelaar

Abstract

Systemic treatment with alitretinoin is registered for all clinical types of severe chronic hand eczema. However, it is especially effective in the hyperkeratotic subtype and less effective in non-hyperkeratotic forms. Cyclosporine A (cyclosporine) is prescribed for hand eczema in daily practice as well. It has shown to be particularly effective in patients with vesicular hand eczema. The primary objective of this study is to compare efficacy of alitretinoin and cyclosporine in the treatment of severe recurrent vesicular hand eczema. This is an investigator-initiated randomised prospective open-label trial with blinded outcome assessment. Severity assessments and laboratory measurements will be conducted corresponding to daily practice. The study population will consist of 72 adult patients (age 18-75 years) with severe recurrent vesicular hand eczema. Patients are treated with either (group I) alitretinoin 30 mg once daily or (group II) cyclosporine with a starting dose of 5 mg/kg/day and a decrease in dosage after 8 weeks to 3-3.5 mg/kg/day. The treatment period is 24 weeks for both drugs. Primary endpoint for efficacy is response to treatment, defined as an improvement of ≥2 steps on a Physician Global Assessment, using a va...Continue Reading

Associated Clinical Trials

Jan 20, 2017·Marie-Louise A Schuttelaar, MD, PhD

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Citations

Jan 30, 2019·Dermatologic Therapy·Griffin R LeeVivian Y Shi
Apr 27, 2019·The Cochrane Database of Systematic Reviews·Wietske Andrea ChristoffersHywel C Williams
Jul 2, 2019·The British Journal of Dermatology·J A F Oosterhaven, M L A Schuttelaar
Sep 14, 2019·Der Hautarzt; Zeitschrift für Dermatologie, Venerologie, und verwandte Gebiete·E Berthold, E Weisshaar
Nov 19, 2021·Expert Opinion on Pharmacotherapy·Maddalena NapolitanoCataldo Patruno

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