Atopic Dermatitis EczemaUPDATENCT05704205
The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema)
A study testing NB-UVB phototherapy and Optimal topical therapy in people with Atopic Dermatitis Eczema and Atopic Dermatitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 16 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis Eczema, Atopic Dermatitis
- What is being tested?
- NB-UVB phototherapy and Optimal topical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 16 sitesNetherlands
- Study dates
- 22 Feb 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Netherlands16 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, 5223 GZ
Centrum Oosterwal
Alkmaar, North Holland, 1817 MS
Flevoziekenhuis
Almere Stad, Flevoland, 1315RA
Meander Medisch Centrum
Amersfoort, Utrecht, 3813 TZ
OLVG
Amsterdam, North Holland, 1061 AE
Amsterdam Universitair Medische Centra
Amsterdam, North Holland, 1105 AZ
Huid Medisch Centrum
Amsterdam, North Holland, 1105 BJ
Reinier de Graaf Gasthuis
Delft, South Holland, 2625 AD
Bergman Clinics
Haarlem, North Holland, 2015 BJ
Spaarne Gasthuis
Hoofddorp, North Holland, 2134 TM
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD
Leids Universitair Medisch Centrum
Leiden, South Holland, 2333 ZA
Alrijne Ziekenhuis
Leiderdorp, South Holland
Dijklander Ziekenhuis
Purmerend, North Holland, 1441 RN
Erasmus Medisch Centrum
Rotterdam, South Holland, 3015 GD
Isala Klinieken
Zwolle, Overijssel
About this study
Official title: The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema): A Multicenter Randomized Controlled Trial of Narrowband UVB Versus Optimized Topical Therapy in Patients With Atopic Eczema
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.
Read the detailed description
Atopic eczema (AE) is a chronic fluctuating dermatological disease characterized by a pruritic inflammation of the skin. The condition poses a high global (financial) burden. One of the therapeutic options of AE is phototherapy, with narrowband UVB (NB-UVB) being the most common. The evidence of the (cost-)effectiveness of NB-UVB, however, is scarce and of low quality.
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
- Atopic Dermatitis Eczema, Atopic Dermatitis
- Being tested
- NB-UVB phototherapy, Optimal topical therapy
- Keywords
- atopic eczema, atopic dermatitis, NB-UVB, phototherapy, optimal topical therapy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB-UVB phototherapyDevice
Also called Narrowband ultraviolet B phototherapy
Narrowband ultraviolet B irradiation 3 times a week
Optimal topical therapyCombination product
Also called OTT, Optimal local 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
| Study group | Role | What they receive |
|---|---|---|
| NB-UVB+OTT | Experimental | 8-16 weeks of NB-UVB phototherapy combined with (a minimum of) 3 months of optimal topical therapy Receives: Device: NB-UVB phototherapy; Combination Product: Optimal topical therapy |
| Optimal topical therapy (OTT) | Active comparator | (a minimum of) 3 months of optimal topical therapy Receives: Combination Product: Optimal topical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (6)
Delta EASI
Change in EASI (Eczema Area and Severity Index) at 3 month follow up
Measured: 3 months
Cost-effectiveness
Questionnaire-based calculation of medical consumption- and productivity costs in both arms
Measured: 1 year
Patient reported outcomes
Questionnaire-based review of quality of life, patient satisfaction
Measured: 1 year
Time to start systemic therapy
The time to start of systemic AE treatment in both arms
Measured: 1 year
Quantity of topical steroid usage
The amount of used topical corticosteroids in both groups
Measured: 1 year
Potency of topical steroid usage
The potency (I-IV) of used topical corticosteroids in both groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start22 Feb 2023
- Primary completion16 Jan 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis EczemaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Prof. Dr. Phyllis I. Spuls, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Louise AA Gerbens, MD PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704205
- Sponsor's protocol ID
- NL81882.018.22
- Acronym
- UPDATE
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39014498
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema): A Multicenter Randomized Controlled Trial of Narrowband UVB Versus Optimized Topical Therapy in Patients With Atopic Eczema
- ClinicalTrials.gov ID
- NCT05704205
- Acronym / sponsor ID
- UPDATE / NL81882.018.22
- Conditions
- Atopic Dermatitis Eczema, Atopic Dermatitis
- Keywords
- atopic eczema, atopic dermatitis, NB-UVB, phototherapy, optimal topical therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Atopic eczema (AE) is a chronic fluctuating dermatological disease characterized by a pruritic inflammation of the skin. The condition poses a high global (financial) burden. One of the therapeutic options of AE is phototherapy, with narrowband UVB (NB-UVB) being the most common. The evidence of the (cost-)effectiveness of NB-UVB, however, is scarce and of low quality.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| NB-UVB+OTT | Experimental | Device: NB-UVB phototherapy, Combination Product: Optimal topical therapy8-16 weeks of NB-UVB phototherapy combined with (a minimum of) 3 months of optimal topical therapy |
| Optimal topical therapy (OTT) | Active comparator | Combination Product: Optimal topical therapy(a minimum of) 3 months of optimal topical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Contra-indication for NB-UVB;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NB-UVB phototherapyAlso: Narrowband ultraviolet B phototherapyNarrowband ultraviolet B irradiation 3 times a week | Device | NB-UVB+OTT |
| Optimal topical therapyAlso: OTT, Optimal local therapyA 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 | Combination product | NB-UVB+OTT, Optimal topical therapy (OTT) |
Primary outcome
Percentage of patients that reach EASI50
Time frame: 3 months
Percentage of patients that reach a 50% reduction of the EASI (Eczema Area and Severity Index) at 3 month follow-up
6 secondary outcomes
Delta EASI
Time frame: 3 months
Cost-effectiveness
Time frame: 1 year
Patient reported outcomes
Time frame: 1 year
Time to start systemic therapy
Time frame: 1 year
Quantity of topical steroid usage
Time frame: 1 year
Potency of topical steroid usage
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 39014498Knops 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise AA Gerbens, MD PhD principal investigator
Amsterdam UMC, location VUmc
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NB-UVB phototherapy and Optimal topical therapy in people with Atopic Dermatitis Eczema and Atopic Dermatitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 16 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients that reach EASI50 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05704205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.