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Completed

NCT Number: NCT01569906

Narrowband UVB for Children With Moderate to Severe Atopic Eczema

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.

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Key information

Conditions

Moderate to Severe Atopic Eczema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Narrowband Ultraviolet B phototherapy

Radiation

Twice weekly exposures for a total of 24 exposures using a standard phototherapy protocol.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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. 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.

  4. 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.

  5. 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. 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.

Sponsors and collaborators

Lead sponsor

Royal Victoria Infirmary

Other

Collaborators

  • British Skin Foundation

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 3, 2012
Registry last updated
Apr 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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