Narrowband UVB for Children With Moderate to Severe Atopic Eczema

NCT ID: NCT01569906

Last Updated: 2012-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Moderate to Severe Atopic Eczema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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UVB

Children with moderate to severe atopic eczema who undertook a standard course of narrowband Ultraviolet B (NBUVB) phototherapy

Narrowband Ultraviolet B phototherapy

Intervention Type RADIATION

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

No interventions assigned to this group

Interventions

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Narrowband Ultraviolet B phototherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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)
Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Skin Foundation

UNKNOWN

Sponsor Role collaborator

Royal Victoria Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Dr AEM Taylor

Consultant Dermatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aileen EM Taylor, MBChB

Role: PRINCIPAL_INVESTIGATOR

Royal Victoria Infirmary

Locations

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Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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7282

Identifier Type: OTHER

Identifier Source: secondary_id

4795

Identifier Type: -

Identifier Source: org_study_id

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