The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema)
NCT ID: NCT05704205
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
316 participants
INTERVENTIONAL
2023-02-22
2026-12-31
Brief Summary
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Half of the participants will undergo a course of NB-UVB phototherapy of 8-16 weeks and apply optimal topical therapy (OTT) for a minimum of 3 months. Researchers will compare the outcomes of this group with the other half of participants that apply OTT only.
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Detailed Description
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The objective of this pragmatic multicenter single blinded randomized controlled trial is comparing the effectiveness and cost-effectiveness of narrowband ultraviolet B with optimal topical therapy (NB-UVB+OTT) versus OTT at 3 months in adult patients with insufficient control of their AE with standard topical treatment, for whom dermatologist and patient jointly believe that NB-UVB or OTT is needed.
Participants that are randomized into the NB-UVB+OTT group will receive an NB-UVB course (at home or at the outpatient clinic) for at least 8 and up to 16 weeks, combined with OTT for at least 3 months. Participants in the control group (OTT group) will apply OTT for at least 3 months. Visits will occur at baseline and 1-3-6-9-12 months after start. At baseline, patient information is collected including an evaluation of medical history and a physical examination to assess Fitzpatrick skin type and physician-reported clinical signs. During each visit patients are asked to fill out questionnaires. Risks are expected to be as in daily practice.
Primary study parameters/outcome of the study is the percentage of patients with EASI50 (a decrease of the Eczema Area and Severity Index of 50%) at 3 month follow-up. Secondary study parameters/outcome of the study include delta EASI, physician-reported clinical signs, patient-reported symptoms, quality of life, long-term control, cost-effectiveness, side effects at 1-3-6-9-12 months, quantity and potency topical steroid usage, time to starting systemic therapy, patient satisfaction with received treatment, percentage of patients reaching Treatment Target goals and percentage of drop-outs with reasons at 3-6-9-12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NB-UVB+OTT
8-16 weeks of NB-UVB phototherapy combined with (a minimum of) 3 months of optimal topical therapy
NB-UVB phototherapy
Narrowband ultraviolet B irradiation 3 times a week
Optimal topical therapy
A combination of detailed instructions about the disease and treatments by trained nurses, bathing and washing advices, adequate emollients use, avoidance of triggers (including possible and proven contact allergens), fingertip unit explanation for active topical therapy, and personalized topical therapy with different potency topical steroids, calcineurin inhibitors and tar ointments
Optimal topical therapy (OTT)
(a minimum of) 3 months of optimal topical therapy
Optimal topical therapy
A combination of detailed instructions about the disease and treatments by trained nurses, bathing and washing advices, adequate emollients use, avoidance of triggers (including possible and proven contact allergens), fingertip unit explanation for active topical therapy, and personalized topical therapy with different potency topical steroids, calcineurin inhibitors and tar ointments
Interventions
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NB-UVB phototherapy
Narrowband ultraviolet B irradiation 3 times a week
Optimal topical therapy
A combination of detailed instructions about the disease and treatments by trained nurses, bathing and washing advices, adequate emollients use, avoidance of triggers (including possible and proven contact allergens), fingertip unit explanation for active topical therapy, and personalized topical therapy with different potency topical steroids, calcineurin inhibitors and tar ointments
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* AE insufficiently controlled by standard topical care and therefore eligible for NB-UVB or OTT;
* Investigator Global Assessment (IGA, 0-4) of ≥ 2 (moderate disease);
* Eczema Area and Severity Index (EASI) of ≥ 7 (moderate disease);
* Understood and voluntarily signed and dated an informed consent form prior to any study-related procedure or has a legal representative who has, and is willing to comply with the study's requirements.
Exclusion Criteria
* Genetic defects associated with photosensitivity or skin cancer;
* Heavily photo-damaged skin;
* History of multiple (\>1) skin malignancies;
* Use of systemic immunosuppressants/immunomodulators;
* Use of medication associated with photosensitivity;
* Patient is already on systemic AE therapy;
* Patient is already on OTT in the past 2 months;
* NB-UVB or any systemic therapy in the past 9 months.
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Prof. Dr. Phyllis I. Spuls
Principal Investigator
Principal Investigators
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Louise AA Gerbens, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam University Medical Centers
Locations
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Flevoziekenhuis
Almere Stad, Flevoland, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands
Centrum Oosterwal
Alkmaar, North Holland, Netherlands
OLVG
Amsterdam, North Holland, Netherlands
Amsterdam Universitair Medische Centra
Amsterdam, North Holland, Netherlands
Huid Medisch Centrum
Amsterdam, North Holland, Netherlands
Bergman Clinics
Haarlem, North Holland, Netherlands
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands
Dijklander Ziekenhuis
Purmerend, North Holland, Netherlands
Isala Klinieken
Zwolle, Overijssel, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
Reinier de Graaf Gasthuis
Delft, South Holland, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Alrijne Ziekenhuis
Leiderdorp, South Holland, Netherlands
Erasmus Medisch Centrum
Rotterdam, South Holland, Netherlands
Meander Medisch Centrum
Amersfoort, Utrecht, Netherlands
Countries
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References
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Knops E, Spuls P, Duijnhoven R, Dijkgraaf M, van Barreveld M, Arents B, van Enst A, Garritsen F, Merkus M, Middelkamp-Hup MA, Musters A, Bosma A, Hyseni A, Dijkstra J, Hijnen DJ, Gerbens L. 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. 2024 Jul 16;25(1):482. doi: 10.1186/s13063-024-08334-z.
Other Identifiers
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NL81882.018.22
Identifier Type: -
Identifier Source: org_study_id
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