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.
Humans
Ultraviolet Therapy
/ economics
Dermatitis, Atopic
/ therapy
Prospective Studies
Multicenter Studies as Topic
Treatment Outcome
Pragmatic Clinical Trials as Topic
Cost-Benefit Analysis
Dermatologic Agents
/ administration & dosage
Adult
Time Factors
Administration, Cutaneous
Randomized Controlled Trials as Topic
Combined Modality Therapy
Severity of Illness Index
Female
Atopic dermatitis
Atopic eczema
Cost-effectiveness
Effectiveness
NB-UVB
Optimal topical therapy
Phototherapy
Randomized controlled trial
Safety
Topical therapy
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
16 Jul 2024
16 Jul 2024
Historique:
received:
11
03
2024
accepted:
11
07
2024
medline:
17
7
2024
pubmed:
17
7
2024
entrez:
16
7
2024
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov NCT05704205. Registered on December 8, 2022.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov NCT05704205. Registered on December 8, 2022.
Identifiants
pubmed: 39014498
doi: 10.1186/s13063-024-08334-z
pii: 10.1186/s13063-024-08334-z
doi:
Substances chimiques
Dermatologic Agents
0
Banques de données
ClinicalTrials.gov
['NCT05704205']
Types de publication
Journal Article
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
482Subventions
Organisme : ZonMw
ID : 10330032010008
Pays : Netherlands
Organisme : Stichting Fonds Onderzoek Huidziekten
ID : 202304-01
Informations de copyright
© 2024. The Author(s).
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