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Narrowband UVB for Children With Moderate to Severe Atopic Eczema

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01569906
First Posted: April 3, 2012
Last Update Posted: April 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
British Skin Foundation
Information provided by (Responsible Party):
Dr AEM Taylor, Royal Victoria Infirmary
  Purpose
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.

Condition Intervention
Moderate to Severe Atopic Eczema Radiation: Narrowband Ultraviolet B phototherapy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Narrowband Ultraviolet B Phototherapy in Children With Moderate to Severe Atopic Eczema- an Observational Prospective Controlled Study

Resource links provided by NLM:


Further study details as provided by Dr AEM Taylor, Royal Victoria Infirmary:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Biospecimen Retention:   Samples With DNA
saliva

Enrollment: 58
Study Start Date: April 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged 3-16 years
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569906


Locations
United Kingdom
Royal Victoria Infirmary
Newcastle-upon-Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Royal Victoria Infirmary
British Skin Foundation
Investigators
Principal Investigator: Aileen EM Taylor, MBChB Royal Victoria Infirmary
  More Information

Responsible Party: Dr AEM Taylor, Consultant Dermatologist, Royal Victoria Infirmary
ClinicalTrials.gov Identifier: NCT01569906     History of Changes
Other Study ID Numbers: 4795
7282 ( Other Identifier: NIHR )
First Submitted: March 30, 2012
First Posted: April 3, 2012
Last Update Posted: April 5, 2012
Last Verified: April 2012

Keywords provided by Dr AEM Taylor, Royal Victoria Infirmary:
Atopic Dermatitis

Additional relevant MeSH terms:
Eczema
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases