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
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...
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BMC
2024-07-01
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| Online Access: | https://doi.org/10.1186/s13063-024-08334-z |
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| author | Eva Knöps Phyllis Spuls Ruben Duijnhoven Marcel Dijkgraaf Marit van Barreveld Bernd Arents Annefloor van Enst Floor Garritsen Maruschka Merkus Maritza Albertina Middelkamp-Hup Annelie Musters Angela Bosma Ariënna Hyseni Jitske Dijkstra Dirk Jan Hijnen Louise Gerbens |
| author_facet | Eva Knöps Phyllis Spuls Ruben Duijnhoven Marcel Dijkgraaf Marit van Barreveld Bernd Arents Annefloor van Enst Floor Garritsen Maruschka Merkus Maritza Albertina Middelkamp-Hup Annelie Musters Angela Bosma Ariënna Hyseni Jitske Dijkstra Dirk Jan Hijnen Louise Gerbens |
| author_sort | Eva Knöps |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-d69cfcf25ead45bdae8a8910754204b1 |
| institution | DOAJ |
| issn | 1745-6215 |
| language | English |
| publishDate | 2024-07-01 |
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| spelling | doaj-art-d69cfcf25ead45bdae8a8910754204b12025-08-20T03:13:18ZengBMCTrials1745-62152024-07-0125111210.1186/s13063-024-08334-zThe 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 eczemaEva Knöps0Phyllis Spuls1Ruben Duijnhoven2Marcel Dijkgraaf3Marit van Barreveld4Bernd Arents5Annefloor van Enst6Floor Garritsen7Maruschka Merkus8Maritza Albertina Middelkamp-Hup9Annelie Musters10Angela Bosma11Ariënna Hyseni12Jitske Dijkstra13Dirk Jan Hijnen14Louise Gerbens15Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of AmsterdamDepartment of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of AmsterdamDepartment of Obstetrics and Gynecology, Amsterdam UMC, Amsterdam Reproduction & Development Research Institute, University of AmsterdamDepartment of Epidemiology and Data Science, Amsterdam University Medical Centers, University of AmsterdamDepartment of Epidemiology and Data Science, Amsterdam University Medical Centers, University of AmsterdamDutch Association for People With Atopic DermatitisNederlandse Vereniging Voor Dermatologie en Venereologie, NVDVDepartment of DermatologyDepartment of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of AmsterdamDepartment of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of AmsterdamDepartment of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of AmsterdamDepartment of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of AmsterdamDepartment of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of AmsterdamDepartment of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of AmsterdamDepartment of Dermatology, Erasmus MC University Medical CenterDepartment of Dermatology, Amsterdam UMC, Location Academic Medical Center, Amsterdam Public Health, Infection and Immunity, University of AmsterdamAbstract 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.https://doi.org/10.1186/s13063-024-08334-zAtopic eczemaAtopic dermatitisPhototherapyNB-UVBTopical therapyOptimal topical therapy |
| spellingShingle | Eva Knöps Phyllis Spuls Ruben Duijnhoven Marcel Dijkgraaf Marit van Barreveld Bernd Arents Annefloor van Enst Floor Garritsen Maruschka Merkus Maritza Albertina Middelkamp-Hup Annelie Musters Angela Bosma Ariënna Hyseni Jitske Dijkstra Dirk Jan Hijnen Louise Gerbens 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 Trials Atopic eczema Atopic dermatitis Phototherapy NB-UVB Topical therapy Optimal topical therapy |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Atopic eczema Atopic dermatitis Phototherapy NB-UVB Topical therapy Optimal topical therapy |
| url | https://doi.org/10.1186/s13063-024-08334-z |
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