The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema)
UPDATE
1 other identifier
interventional
316
1 country
16
Brief Summary
The goal of this randomized controlled trial is to study the (cost)effectiveness of NB-UVB phototherapy in patients with atopic eczema/atopic dermatitis. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2022
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedStudy Start
First participant enrolled
February 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJanuary 23, 2026
January 1, 2026
2.9 years
December 8, 2022
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients that reach EASI50
Percentage of patients that reach a 50% reduction of the EASI (Eczema Area and Severity Index) at 3 month follow-up
3 months
Secondary Outcomes (6)
Delta EASI
3 months
Cost-effectiveness
1 year
Patient reported outcomes
1 year
Time to start systemic therapy
1 year
Quantity of topical steroid usage
1 year
- +1 more secondary outcomes
Study Arms (2)
NB-UVB+OTT
EXPERIMENTAL8-16 weeks of NB-UVB phototherapy combined with (a minimum of) 3 months of optimal topical therapy
Optimal topical therapy (OTT)
ACTIVE COMPARATOR(a minimum of) 3 months of optimal topical therapy
Interventions
Narrowband ultraviolet B irradiation 3 times a week
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
Eligibility Criteria
You may qualify if:
- Adult (≥18 years of age) patient meeting the UK working party criteria for atopic eczema;
- 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.
You may not qualify if:
- Contra-indication for NB-UVB;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Flevoziekenhuis
Almere Stad, Flevoland, 1315RA, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands
Centrum Oosterwal
Alkmaar, North Holland, 1817 MS, Netherlands
OLVG
Amsterdam, North Holland, 1061 AE, Netherlands
Amsterdam Universitair Medische Centra
Amsterdam, North Holland, 1105 AZ, Netherlands
Huid Medisch Centrum
Amsterdam, North Holland, 1105 BJ, Netherlands
Bergman Clinics
Haarlem, North Holland, 2015 BJ, Netherlands
Spaarne Gasthuis
Hoofddorp, North Holland, 2134 TM, Netherlands
Dijklander Ziekenhuis
Purmerend, North Holland, 1441 RN, Netherlands
Isala Klinieken
Zwolle, Overijssel, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD, Netherlands
Reinier de Graaf Gasthuis
Delft, South Holland, 2625 AD, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, 2333 ZA, Netherlands
Alrijne Ziekenhuis
Leiderdorp, South Holland, Netherlands
Erasmus Medisch Centrum
Rotterdam, South Holland, 3015 GD, Netherlands
Meander Medisch Centrum
Amersfoort, Utrecht, 3813 TZ, Netherlands
Related Publications (1)
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.
PMID: 39014498DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louise AA Gerbens, MD PhD
Amsterdam University Medical Centers
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Single blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 8, 2022
First Posted
January 30, 2023
Study Start
February 22, 2023
Primary Completion
January 16, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share