Narrowband UVB for Children With Moderate to Severe Atopic Eczema

April 3, 2012 updated by: Dr AEM Taylor, Royal Victoria Infirmary

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Newcastle-upon-Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children aged 3-16 years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score at the end of treatment compared to the control group
Time Frame: 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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective scores at the end of treatment as compared to controls
Time Frame: 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
12 weeks
objective scores at 3 months post treatment compared to controls
Time Frame: 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.
3 months
Association of filaggrin status with outcome
Time Frame: 12 weeks
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
Time Frame: 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.
3 months
Subjective scores at 6 months post treatment compared to controls
Time Frame: 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.
6 months
Objective scores at 6 months post treatment compared to controls
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Victoria Infirmary

Collaborators

British Skin Foundation

Investigators

  • Principal Investigator: Aileen EM Taylor, MBChB, Royal Victoria Infirmary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

March 30, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 3, 2012

Study Record Updates

Last Update Posted (Estimate)

April 5, 2012

Last Update Submitted That Met QC Criteria

April 3, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4795
  • 7282 (NIHR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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