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
Eva Knöps,
Phyllis Spuls,
Ruben Duijnhoven,
Marcel Dijkgraaf,
Marit van Barreveld,
Bernd Arents,
Annefloor van Enst,
Floor Garritsen,
Maruschka Merkus,
Pina Middelkamp-Hup,
Annelie Musters,
Angela Bosma,
Ariënna Hyseni,
Jitske Dijkstra,
Dirk Jan Hijnen,
Louise Gerbens
Affiliations
Eva Knöps
Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam
Phyllis Spuls
Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam
Ruben Duijnhoven
Department of Obstetrics and Gynecology, Amsterdam UMC, Amsterdam Reproduction & Development Research Institute, University of Amsterdam
Marcel Dijkgraaf
Department of Epidemiology and Data Science, Amsterdam University Medical Centers, University of Amsterdam
Marit van Barreveld
Department of Epidemiology and Data Science, Amsterdam University Medical Centers, University of Amsterdam
Bernd Arents
Dutch Association for People With Atopic Dermatitis
Annefloor van Enst
Nederlandse Vereniging Voor Dermatologie en Venereologie, NVDV
Floor Garritsen
Department of Dermatology
Maruschka Merkus
Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam
Pina Middelkamp-Hup
Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam
Annelie Musters
Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam
Angela Bosma
Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam
Ariënna Hyseni
Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam
Jitske Dijkstra
Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam
Dirk Jan Hijnen
Department of Dermatology, Erasmus MC University Medical Center
Louise Gerbens
Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam
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 ClinicalTrials.gov NCT05704205. Registered on December 8, 2022.