Narrowband UVB for Children With Moderate to Severe Atopic Eczema
Narrowband Ultraviolet B Phototherapy in Children With Moderate to Severe Atopic Eczema- an Observational Prospective Controlled Study
2 other identifiers
observational
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 30, 2012
CompletedFirst Posted
Study publicly available on registry
April 3, 2012
CompletedApril 5, 2012
April 1, 2012
1.3 years
March 30, 2012
April 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score at the end of treatment compared to the control group
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 Outcomes (6)
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
Subjective scores at 3 months post treatment compared to controls
3 months
Subjective scores at 6 months post treatment compared to controls
6 months
- +1 more secondary outcomes
Study Arms (2)
UVB
Children with moderate to severe atopic eczema who undertook a standard course of narrowband Ultraviolet B (NBUVB) phototherapy
Controls
Children with moderate to severe atopic eczema who were offered UVB but were unable to undertake treatment
Interventions
Twice weekly exposures for a total of 24 exposures using a standard phototherapy protocol.
Eligibility Criteria
Children aged 3-16 years
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Victoria Infirmarylead
- British Skin Foundationcollaborator
Study Sites (1)
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Biospecimen
saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aileen EM Taylor, MBChB
Royal Victoria Infirmary
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Dermatologist
Study Record Dates
First Submitted
March 30, 2012
First Posted
April 3, 2012
Study Start
April 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
April 5, 2012
Record last verified: 2012-04