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Clinical Trial Details for Narrowband Ultraviolet B Versus Narrowband Ultraviolet B Plus Ultraviolet A1 for Atopic Eczema


University of Dundee
NCT ID: NCT02915146
Last Updated: November 5, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: N/A
  • Gender: All
  • Age: 12 Years - N/A
  • Condition: Atopic Eczema
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: University of Dundee
  • Location: Not Provided

Official Title

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

Purpose

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.

Eligibility

Ages Eligible for Study

12 Years to N/A

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Accepts Healthy Volunteers

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

Additional Information, Locations & Contacts

Sponsors & Collaborators

University of Dundee

NHS Tayside

Investigators

Principal Investigator: Robert S Dawe

NHS Tayside and University of Dundee

Please refer to this study by its ClinicalTrials.gov identifier: NCT02915146

Location

Contacts

Ninewells Hospital

Dundee, DD1 9SY

United Kingdom

Robert S Dawe, MD, FRCP