TY - JOUR
T1 - The UPDATE trial (UVBPhototherapy in Dermatology for ATopic Eczema)
T2 - study protocol for a randomized controlled trial of narrowband UVB with optimal topical therapy versus optimal topical therapy in patients with atopic eczema
AU - Knöps, Eva
AU - Spuls, Phyllis
AU - Duijnhoven, Ruben
AU - Dijkgraaf, Marcel
AU - van Barreveld, Marit
AU - Arents, Bernd
AU - van Enst, Annefloor
AU - Garritsen, Floor
AU - Merkus, Maruschka
AU - Middelkamp-Hup, Pina
AU - Musters, Annelie
AU - Bosma, Angela
AU - Hyseni, Ariënna
AU - Dijkstra, Jitske
AU - Hijnen, Dirk Jan
AU - Gerbens, Louise
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/7/16
Y1 - 2024/7/16
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85198723161&partnerID=8YFLogxK
U2 - 10.1186/s13063-024-08334-z
DO - 10.1186/s13063-024-08334-z
M3 - Article
C2 - 39014498
AN - SCOPUS:85198723161
SN - 1745-6215
VL - 25
JO - Trials
JF - Trials
IS - 1
M1 - 482
ER -