Trials (Jul 2024)

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

DOI
https://doi.org/10.1186/s13063-024-08334-z
Journal volume & issue
Vol. 25, no. 1
pp. 1 – 12

Abstract

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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.

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