Back to resultsNarrowband Ultraviolet B Versus Narrowband Ultraviolet B Plus Ultraviolet A1 for Atopic Eczema
Primary Purpose
Atopic Eczema
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Eczema focused on measuring eczema, phototherapy, uva1, uvb, adults, children
Eligibility Criteria
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
Sites / Locations
- Ninewells Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NB-UVB monotherapy
NB-UVB + UVA1
Arm Description
Narrowband ultraviolet B monotherapy will be used
Narrowband ultraviolet B combined with ultraviolet A1 phototherapy will be used
Outcomes
Primary Outcome Measures
Change in EASI (eczema severity score) - proportions reaching 50% reduction
observer-assessed eczema severity
Secondary Outcome Measures
POEM (patient orientated eczema measure)
patient-assessed eczema severity
Full Information
NCT ID
NCT02915146
First Posted
August 4, 2016
Last Updated
November 5, 2020
Sponsor
University of Dundee
Collaborators
NHS Tayside
1. Study Identification
Unique Protocol Identification Number
NCT02915146
Brief Title
Narrowband Ultraviolet B Versus Narrowband Ultraviolet B Plus Ultraviolet A1 for Atopic Eczema
Official Title
A Randomised Assessor-blinded Study to Compare Narrowband Ultraviolet B With Combined Narrowband Ultraviolet B and Ultraviolet A1 for Atopic Eczema
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 26, 2020 (Actual)
Study Completion Date
August 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Dundee
Collaborators
NHS Tayside
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Eczema
Keywords
eczema, phototherapy, uva1, uvb, adults, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NB-UVB monotherapy
Arm Type
Active Comparator
Arm Description
Narrowband ultraviolet B monotherapy will be used
Arm Title
NB-UVB + UVA1
Arm Type
Active Comparator
Arm Description
Narrowband ultraviolet B combined with ultraviolet A1 phototherapy will be used
Intervention Type
Radiation
Intervention Name(s)
combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy
Intervention Description
NB-UVB combined with UVA1
Primary Outcome Measure Information:
Title
Change in EASI (eczema severity score) - proportions reaching 50% reduction
Description
observer-assessed eczema severity
Time Frame
From beginning to end of treatment (25 weeks)
Secondary Outcome Measure Information:
Title
POEM (patient orientated eczema measure)
Description
patient-assessed eczema severity
Time Frame
26 weeks after treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Dawe
Organizational Affiliation
NHS Tayside and University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Narrowband Ultraviolet B Versus Narrowband Ultraviolet B Plus Ultraviolet A1 for Atopic Eczema
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