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Completed

NCT Number: NCT02915146

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

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.

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Key information

Conditions

Atopic Eczema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Radiation

NB-UVB combined with UVA1

Primary outcomes

  1. Change in EASI (eczema severity score) - proportions reaching 50% reduction

    Time frame: From beginning to end of treatment (25 weeks)

    observer-assessed eczema severity

Secondary outcomes

  1. POEM (patient orientated eczema measure)

    Time frame: 26 weeks after treatment completion

    patient-assessed eczema severity

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • NHS Tayside

Registry information

Official study title

A Randomised Assessor-blinded Study to Compare Narrowband Ultraviolet B With Combined Narrowband Ultraviolet B and Ultraviolet A1 for Atopic Eczema

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2016
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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