The UPDATE trial (UVB Phototherapy in Dermatology for ATopic Eczema): study protocol for a randomized controlled trial of narrowband UVB with optimal topical therapy versus optimal topical therapy in patients with atopic eczema

Author:

Knöps Eva1ORCID,Spuls Phyllis Ira1,Duijnhoven Ruben G1,Dijkgraaf Marcel Gerrit Willem1,Barreveld Marit van1,Arents Bernd Wilhelm Menno2,Enst Wynanda Annefloor van3,Garritsen Floralie Maria4,Merkus Maruschka Patricia1,Middelkamp-Hup Maritza Albertina1,Musters Annelie Hanna1,Bosma Angela Leigh-Ann1,Hyseni Ariënna Melissa1,Dijkstra Jitske1,Hijnen Dirk Jan5,Gerbens Louise Anna Andrea1

Affiliation:

1. Amsterdam UMC - Locatie AMC: Amsterdam UMC Locatie AMC

2. Dutch Association for People with Atopic Dermatitis

3. Nederlandse Vereniging voor Dermatologie en Venereologie

4. Haga Hospital: HagaZiekenhuis

5. Erasmus Medical Centre: Erasmus MC

Abstract

Abstract

Background Narrowband Ultraviolet B (NB-UVB) phototherapy is commonly prescribed for patients with moderate-to-severe atopic eczema (AE). The efficacy of NB-UVB, however, has not yet properly been established, as current evidence is of low certainty. Our aim is to assess the short-term and long-term (cost)effectiveness and safety of NB-UVB in adult AE patients by performing a pragmatic, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial. This protocol outlines its methodology. Methods A pragmatic, multicenter, PROBE trial will be performed with 1:1 randomization of 316 adult patients with moderate-to-severe AE who have inadequate disease control with topical therapy and who are eligible for optimal topical therapy (OTT) or NB-UVB in combination with OTT as a next step. Participants in the interventional arm will receive a minimum of 3 months of OTT combined with 8 to 16 weeks of NB-UVB. The control group receives 3 months of OTT. Following the interventional phase, follow-up will continue for 9 months. Physician-reported and patient-reported outcomes (according to the Harmonising Outcome Measures for Eczema (HOME) Core Outcome Set) and adverse events are assessed at 4 weeks, 3, 6, 9 and 12 months. Discussion The UPDATE trial aims to provide high-quality evidence regarding the (cost-)effectiveness and safety of NB-UVB phototherapy in moderate-to-severe AE patients. Challenges that are addressed in the protocol include the possible bias arising from applying open label treatment, and the necessity of introducing OTT into the study design to prevent a high dropout rate. Trial registration {2a} {2b} ClinicalTrials.gov Identifier: NCT05704205, registered on December 8th 2022, https://clinicaltrials.gov/study/NCT05704205

Publisher

Springer Science and Business Media LLC

Reference44 articles.

1. Work ability and quality of working life in atopic dermatitis patients treated with dupilumab;Bosma AL;J Dermatol,2021

2. Nielen MMJ. Constitutioneel eczeem: Volksgezondheid en Zorg; 2020 [updated 28-3-202230-6-2022]. Available from: https://www.vzinfo.nl/constitutioneel-eczeem/leeftijd-en-geslacht.

3. Atopic dermatitis: global epidemiology and risk factors;Nutten S;Ann Nutr Metab,2015

4. The global burden of skin disease in 2010: an analysis of the prevalence and impact of skin conditions;Hay RJ;J Invest Dermatol,2014

5. European guideline (EuroGuiDerm) on atopic eczema: part I - systemic therapy;Wollenberg A;J Eur Acad Dermatol Venereol,2022

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