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Narrowband Ultraviolet B Versus Narrowband Ultraviolet B Plus Ultraviolet A1 for Atopic Eczema

NCT ID: NCT02915146

Last Updated: 2020-11-06

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

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-08-26

Brief Summary

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Narrowband ultraviolet B phototherapy is the "standard" phototherapy for atopic eczema; ultraviolet A1 is sometimes used but is not a widely available treatment. We do not know the most important chromophores in treating atopic eczema; in which phototherapy is thought to work by improving epidermal barrier function, having beneficial effects on skin microbiome and local immunosuppression. It seems plausible that there are several chromophores and that 'targetting' several at once with different wavebands should help and for severe eczema that has not responded adequately to narrowband UVB or ultraviolet A1 alone the combination is sometimes used. This study is to test if the combination is moderately to greatly more effective than narrowband ultraviolet B monotherapy amongst patients referred for any form of first-line phototherapy for atopic eczema.

Detailed Description

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Narrowband ultraviolet B phototherapy is the "standard" phototherapy widely used for atopic eczema; ultraviolet A1 is sometimes used but is not a widely available treatment. We do not know the most important chromophores in treating atopic eczema; in which phototherapy is thought to work by improving epidermal barrier function, having beneficial effects on skin microbiome and local immunosuppression.

It seems plausible that there are several chromophores (the molecules that absorb the ultraviolet photons to set in chain the effects we are aiming for) and that 'targetting' several chromophores at once with different wavebands should help. For severe eczema that has not responded adequately to narrowband UVB or ultraviolet A1 alone the combination is sometimes used in the few centres where UVA1 is available.

This study is to test if the combination is moderately to greatly more effective than narrowband ultraviolet B monotherapy amongst patients referred for any form of first-line phototherapy for atopic eczema.

Conditions

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Atopic Eczema

Keywords

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eczema phototherapy uva1 uvb adults children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NB-UVB monotherapy

Narrowband ultraviolet B monotherapy will be used

Group Type ACTIVE_COMPARATOR

combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy

Intervention Type RADIATION

NB-UVB combined with UVA1

NB-UVB + UVA1

Narrowband ultraviolet B combined with ultraviolet A1 phototherapy will be used

Group Type ACTIVE_COMPARATOR

combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy

Intervention Type RADIATION

NB-UVB combined with UVA1

Interventions

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combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy

NB-UVB combined with UVA1

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients with atopic eczema as diagnosed by a dermatologist, defined according to the UK Working Party diagnostic criteria, considered for any form of whole body phototherapy
* Age 12 years and above
* Able to understand and comply with protocol requirements and treatment visits, instructions and protocol stated restrictions
* Provision of written informed consent in accordance with the Scottish Children's Network consent guidance and standard operating procedure (SOP) for subjects aged 12-15 years
* Provision of written informed consent (subjects age 16 years and over)

Exclusion Criteria

* Unable to provide written informed consent in accordance with the Scottish Children's Network consent guidance and SOP
* Unable to provide written informed consent (subjects age 16 years and over)
* Currently being treated, or treated within the past 2 weeks, with systemic immunosuppressive therapy
* Current use of drugs known to cause photosensitivity
* Phototherapy, photochemotherapy, or sunbed use in the preceding 3 months
* Known abnormal photosensitivity
* Previous history of skin cancer
* Participation in another research study within the past three months
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Tayside

OTHER_GOV

Sponsor Role collaborator

University of Dundee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert S Dawe

Role: PRINCIPAL_INVESTIGATOR

NHS Tayside and University of Dundee

Locations

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Ninewells Hospital

Dundee, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2015DS04

Identifier Type: -

Identifier Source: org_study_id