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Clinical Trials/NCT01569906
NCT01569906
Completed
Not Applicable

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

Royal Victoria Infirmary1 site in 1 country58 target enrollmentApril 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Moderate to Severe Atopic Eczema
Sponsor
Royal Victoria Infirmary
Enrollment
58
Locations
1
Primary Endpoint
Score at the end of treatment compared to the control group
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
August 2010
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr AEM Taylor

Consultant Dermatologist

Royal Victoria Infirmary

Eligibility 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)

Outcomes

Primary Outcomes

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

  • Subjective scores at the end of treatment as compared to controls(12 weeks)
  • objective scores at 3 months post treatment compared to controls(3 months)
  • Association of filaggrin status with outcome(12 weeks)
  • Objective scores at 6 months post treatment compared to controls(6 months)
  • Subjective scores at 3 months post treatment compared to controls(3 months)
  • Subjective scores at 6 months post treatment compared to controls(6 months)

Study Sites (1)

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