Narrowband UVB for Children With Moderate to Severe Atopic Eczema

Study Overview
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Brief Summary
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To assess prospectively, the response of moderate to severe atopic eczema to a standard course of narrowband ultraviolet B phototherapy by using validated objective and subjective scoring systems.

Detailed Description
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Children with moderate to severe atopic eczema prescribed a course of narrowband UVB phototherapy were scored (using validated scoring systems) objectively and subjectively before, during and after the course of treatment, as well as 3 and 6 months post treatment (to determine length of remission). Their scores were compared to a control group. The control group comprised children with moderate to severe atopic eczema who were offered UVB but were unable to undertake the treatment.

Official Title
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Narrowband Ultraviolet B Phototherapy in Children With Moderate to Severe Atopic Eczema- an Observational Prospective Controlled Study

Conditions
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Moderate to Severe Atopic Eczema

Intervention / Treatment
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* Radiation: Narrowband Ultraviolet B phototherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 3-16 years with moderate to severe atopic eczema (as defined by the modified Hannifin and Rajka criteria) in whom there is a clinical indication for phototherapy (as deemed by their specialist Dermatology consultant). Exclusion Criteria: Children under the age of 3 years or any child who lacks the maturity needed to stand in the phototherapy cabinet unsupervised. Mild disease (defined as a Six Area Six Sign Atopic Dermatitis (SASSAD) score <10)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 16 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UVB<br>Children with moderate to severe atopic eczema who undertook a standard course of narrowband Ultraviolet B (NBUVB) phototherapy | Radiation: Narrowband Ultraviolet B phototherapy<br>* Twice weekly exposures for a total of 24 exposures using a standard phototherapy protocol.<br>|
| Controls<br>Children with moderate to severe atopic eczema who were offered UVB but were unable to undertake treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score at the end of treatment compared to the control group | Measurement of Six Area Six Sign Atopic Dermatitis (SASSAD) score and percentage surface area affected of those treated with narrowband UVB as compared to a control group | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective scores at the end of treatment as compared to controls | Subjective scoring using Patient Outcome Eczema Measure (POEM), Children's Dermatology Life Quality Index (CDLQI), Dermatitis Family Impact Questionnaire (DFI), Visual analogue scale (VAS) for itch and sleep loss | 12 weeks | 
| objective scores at 3 months post treatment compared to controls | Objective Six Area Six Sign Atopic Dermatitis (SASSAD) score and percentage surface area affected in the treated group at 3 months post treatment as compared to controls. | 3 months | 
| Association of filaggrin status with outcome | To determine if response to phototherapy is determined by the presence of a homozygous or compound heterozygous filaggrin mutation. | 12 weeks | 
| Subjective scores at 3 months post treatment compared to controls | Subjective scores (Patient Outcome Eczema Measure (POEM),Children's Dermatology Life Quality Index (CDLQI), Dermatitis Family Impact Questionnaire (DFI), Visual Analogue Scale (VAS) for itch and sleep loss) in the treated group at 3 months post treatment as compared to controls. | 3 months | 
| Subjective scores at 6 months post treatment compared to controls | Subjective scores (Patient Outcome Eczema Measure (POEM),Children's Dermatology Life Quality Index (CDLQI), Dermatitis Family Impact Questionnaire (DFI), Visual Analogue Scale (VAS) for itch and sleep loss) in the treated group at 6 months post treatment as compared to controls. | 6 months | 
| Objective scores at 6 months post treatment compared to controls | Objective Six Area Six Sign Atopic Dermatitis (SASSAD) score and percentage surface area affected in the treated group at 6 months post treatment as compared to controls. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis