Narrowband Ultraviolet B Versus Narrowband Ultraviolet B Plus Ultraviolet A1 for Atopic Eczema

Study Overview
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Brief Summary
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Narrowband ultraviolet B phototherapy is the standard phototherapy for atopic eczema; ultraviolet A1 is sometimes used but is not a widely available treatment. We do not know the most important chromophores in treating atopic eczema; in which phototherapy is thought to work by improving epidermal barrier function, having beneficial effects on skin microbiome and local immunosuppression. It seems plausible that there are several chromophores and that 'targetting' several at once with different wavebands should help and for severe eczema that has not responded adequately to narrowband UVB or ultraviolet A1 alone the combination is sometimes used. This study is to test if the combination is moderately to greatly more effective than narrowband ultraviolet B monotherapy amongst patients referred for any form of first-line phototherapy for atopic eczema.

Detailed Description
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Narrowband ultraviolet B phototherapy is the standard phototherapy widely used for atopic eczema; ultraviolet A1 is sometimes used but is not a widely available treatment. We do not know the most important chromophores in treating atopic eczema; in which phototherapy is thought to work by improving epidermal barrier function, having beneficial effects on skin microbiome and local immunosuppression. It seems plausible that there are several chromophores (the molecules that absorb the ultraviolet photons to set in chain the effects we are aiming for) and that 'targetting' several chromophores at once with different wavebands should help. For severe eczema that has not responded adequately to narrowband UVB or ultraviolet A1 alone the combination is sometimes used in the few centres where UVA1 is available. This study is to test if the combination is moderately to greatly more effective than narrowband ultraviolet B monotherapy amongst patients referred for any form of first-line phototherapy for atopic eczema.

Official Title
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A Randomised Assessor-blinded Study to Compare Narrowband Ultraviolet B With Combined Narrowband Ultraviolet B and Ultraviolet A1 for Atopic Eczema

Conditions
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Atopic Eczema

Intervention / Treatment
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* Radiation: combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with atopic eczema as diagnosed by a dermatologist, defined according to the UK Working Party diagnostic criteria, considered for any form of whole body phototherapy Age 12 years and above Able to understand and comply with protocol requirements and treatment visits, instructions and protocol stated restrictions Provision of written informed consent in accordance with the Scottish Children's Network consent guidance and standard operating procedure (SOP) for subjects aged 12-15 years Provision of written informed consent (subjects age 16 years and over) Exclusion Criteria: Unable to provide written informed consent in accordance with the Scottish Children's Network consent guidance and SOP Unable to provide written informed consent (subjects age 16 years and over) Currently being treated, or treated within the past 2 weeks, with systemic immunosuppressive therapy Current use of drugs known to cause photosensitivity Phototherapy, photochemotherapy, or sunbed use in the preceding 3 months Known abnormal photosensitivity Previous history of skin cancer Participation in another research study within the past three months

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NB-UVB monotherapy<br>Narrowband ultraviolet B monotherapy will be used | Radiation: combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy<br>* NB-UVB combined with UVA1<br>|
| Active Comparator: NB-UVB + UVA1<br>Narrowband ultraviolet B combined with ultraviolet A1 phototherapy will be used | Radiation: combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy<br>* NB-UVB combined with UVA1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EASI (eczema severity score) - proportions reaching 50% reduction | observer-assessed eczema severity | From beginning to end of treatment (25 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POEM (patient orientated eczema measure) | patient-assessed eczema severity | 26 weeks after treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uvb, eczema, phototherapy, uva1, adults, children