Clinical trial NCT02915146: 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
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Eczema
Keywords: eczema
phototherapy
uva1
uvb
adults
children
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: NHS Tayside
First posted: 2016-09-26
Enrollment: 39
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in EASI (eczema severity score) - proportions reaching 50% reduction
timeFrame: From beginning to end of treatment (25 weeks)
Secondary outcomes:
measure: POEM (patient orientated eczema measure)
timeFrame: 26 weeks after treatment completion
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
Study officials:
affiliation: NHS Tayside and University of Dundee
name: Robert S Dawe
role: PRINCIPAL_INVESTIGATOR
References: