The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Atopic Dermatitis Eczema, Atopic Dermatitis

Intervention / Treatment
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* Device: NB-UVB phototherapy
* Combination Product: Optimal topical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NB-UVB+OTT<br>8-16 weeks of NB-UVB phototherapy combined with (a minimum of) 3 months of optimal topical therapy | Device: NB-UVB phototherapy<br>* Narrowband ultraviolet B irradiation 3 times a week<br>* Other names: Narrowband ultraviolet B phototherapy;Combination Product: Optimal topical therapy<br>* 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<br>* Other names: Optimal local therapy;|
| Active Comparator: Optimal topical therapy (OTT)<br>(a minimum of) 3 months of optimal topical therapy | Combination Product: Optimal topical therapy<br>* 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<br>* Other names: Optimal local therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic eczema, atopic dermatitis, NB-UVB, phototherapy, optimal topical therapy