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.

Autor: Knöps E; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam, Amsterdam, The Netherlands. e.knops@amsterdamumc.nl., Spuls P; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam, Amsterdam, The Netherlands., Duijnhoven R; Department of Obstetrics and Gynecology, Amsterdam UMC, Amsterdam Reproduction & Development Research Institute, University of Amsterdam, Amsterdam, the Netherlands., Dijkgraaf M; Department of Epidemiology and Data Science, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands., van Barreveld M; Department of Epidemiology and Data Science, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands., Arents B; Dutch Association for People With Atopic Dermatitis, Nijkerk, the Netherlands., van Enst A; Nederlandse Vereniging Voor Dermatologie en Venereologie, NVDV, Utrecht, the Netherlands., Garritsen F; Department of Dermatology, HagaZiekenhuis, The Hague, the Netherlands., Merkus M; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam, Amsterdam, The Netherlands., Middelkamp-Hup P; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam, Amsterdam, The Netherlands., Musters A; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam, Amsterdam, The Netherlands., Bosma A; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam, Amsterdam, The Netherlands., Hyseni A; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam, Amsterdam, The Netherlands., Dijkstra J; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam, Amsterdam, The Netherlands., Hijnen DJ; Department of Dermatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands., Gerbens L; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of Amsterdam, Amsterdam, The Netherlands.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Jul 16; Vol. 25 (1), pp. 482. Date of Electronic Publication: 2024 Jul 16.
DOI: 10.1186/s13063-024-08334-z
Abstrakt: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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