Narrowband UVB for Children With Moderate to Severe Atopic Eczema

Completed

• Conditions: Moderate to Severe Atopic Eczema
• Interventions: Radiation: Narrowband Ultraviolet B phototherapy

• Registration Number: NCT01569906
• Lead Sponsor: Royal Victoria Infirmary

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-03-30
• Status Verified: 2012-04
• Study First Posted: 2012-04-03
• Last Update Submitted: 2012-04-03
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UVB	Narrowband Ultraviolet B phototherapy	Children with moderate to severe atopic eczema who undertook a standard course of narrowband Ultraviolet B (NBUVB) phototherapy

Primary Outcome Measures

Name	Time	Method
Score at the end of treatment compared to the control group	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Subjective scores at the end of treatment as compared to controls	12 weeks	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
objective scores at 3 months post treatment compared to controls	3 months	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.
Association of filaggrin status with outcome	12 weeks	To determine if response to phototherapy is determined by the presence of a homozygous or compound heterozygous filaggrin mutation.
Objective scores at 6 months post treatment compared to controls	6 months	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.
Subjective scores at 3 months post treatment compared to controls	3 months	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.
Subjective scores at 6 months post treatment compared to controls	6 months	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.

Trial Locations

Locations (1)

Royal Victoria Infirmary; 🇬🇧 Newcastle-upon-Tyne, United Kingdom