Narrowband UVB for Children With Moderate to Severe Atopic Eczema

This study has been completed.
Sponsor:
Collaborator:
British Skin Foundation
Information provided by (Responsible Party):
Dr AEM Taylor, Royal Victoria Infirmary
ClinicalTrials.gov Identifier:
NCT01569906
First received: March 30, 2012
Last updated: April 3, 2012
Last verified: April 2012
  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 Royal Victoria Infirmary:

Primary Outcome Measures:
  • Score at the end of treatment compared to the control group [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr AEM Taylor, Consultant Dermatologist, Royal Victoria Infirmary
ClinicalTrials.gov Identifier: NCT01569906     History of Changes
Other Study ID Numbers: 4795, 7282
Study First Received: March 30, 2012
Last Updated: April 3, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Institute for Health Research

Keywords provided by Royal Victoria Infirmary:
Atopic Dermatitis

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

ClinicalTrials.gov processed this record on July 29, 2014