Journal Article

The UPDATE trial (UVBPhototherapy 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

Gerbens, Louise, van Enst, Annefloor, Merkus, Maruschka, Dijkstra, Jitske, Hyseni, Ariënna, Arents, Bernd, Dijkgraaf, Marcel, Garritsen, Floor, Spuls, Phyllis, Bosma, Angela, Musters, Annelie, van Barreveld, Marit, Knöps, Eva, Duijnhoven, Ruben, Middelkamp-Hup, Maritza Albertina, Hijnen, Dirk Jan

2024

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Administration, Cutaneous / Adult / Allergens / Atopic dermatitis / Atopic eczema / Biomedicine / Care and treatment / Clinical trials / Combined Modality Therapy / Cost-Benefit Analysis / Dermatitis / Dermatitis, Atopic - diagnosis / Dermatitis, Atopic - economics / Dermatitis, Atopic - therapy / Dermatologic Agents - administration & dosage / Dermatologic Agents - adverse effects / Dermatologic Agents - economics / Dermatologic Agents - therapeutic use / Dermatology / Disease control / Eczema / Female / Fluorescent lighting / Health Sciences / Humans / Informed consent / Light therapy / Medicine / Medicine & Public Health / Melanoma / Multicenter Studies as Topic / NB-UVB / Optimal topical therapy / Patients / Phototherapy / Pragmatic Clinical Trials as Topic / Prospective Studies / Randomized Controlled Trials as Topic / Reimbursement / Severity of Illness Index / Skin cancer / Skin care products / Statistics for Life Sciences / Steroids / Study Protocol / Time Factors / Topical therapy / Treatment Outcome / Ultraviolet Therapy - adverse effects / Ultraviolet Therapy - economics / Ultraviolet Therapy - methods