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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NB-UVB+OTT | Experimental | 8-16 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NB-UVB phototherapy | Device | Narrowband ultraviolet B irradiation 3 times a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Delta EASI | Change in EASI (Eczema Area and Severity Index) at 3 month follow up | 3 months |
| Cost-effectiveness | Questionnaire-based calculation of medical consumption- and productivity costs in both arms |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Louise AA Gerbens, MD PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flevoziekenhuis | Almere Stad | Flevoland | 1315RA | Netherlands | ||
| Jeroen Bosch Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39014498 | Derived | 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. |
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Randomized controlled trial
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Single blinded
| Optimal topical therapy | Combination Product | 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 |
|
|
| 1 year |
| Patient reported outcomes | Questionnaire-based review of quality of life, patient satisfaction | 1 year |
| Time to start systemic therapy | The time to start of systemic AE treatment in both arms | 1 year |
| Quantity of topical steroid usage | The amount of used topical corticosteroids in both groups | 1 year |
| Potency of topical steroid usage | The potency (I-IV) of used topical corticosteroids in both groups | 1 year |
| '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 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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