Narrowband Ultraviolet B Versus Narrowband Ultraviolet B Plus Ultraviolet A1 for Atopic Eczema
A Randomised Assessor-blinded Study to Compare Narrowband Ultraviolet B With Combined Narrowband Ultraviolet B and Ultraviolet A1 for Atopic Eczema
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Dundee, United Kingdom, DD1 9SY
- Ninewells Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: NB-UVB monotherapy
Narrowband ultraviolet B monotherapy will be used
|
NB-UVB combined with UVA1
|
|
Active Comparator: NB-UVB + UVA1
Narrowband ultraviolet B combined with ultraviolet A1 phototherapy will be used
|
NB-UVB combined with UVA1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in EASI (eczema severity score) - proportions reaching 50% reduction
Time Frame: From beginning to end of treatment (25 weeks)
|
observer-assessed eczema severity
|
From beginning to end of treatment (25 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
POEM (patient orientated eczema measure)
Time Frame: 26 weeks after treatment completion
|
patient-assessed eczema severity
|
26 weeks after treatment completion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert S Dawe, NHS Tayside and University of Dundee
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015DS04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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