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Trial record 3 of 838 for:    eczema

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

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ClinicalTrials.gov Identifier: NCT02915146
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
NHS Tayside
Information provided by (Responsible Party):
Robert Dawe, University of Dundee

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.

Condition or disease Intervention/treatment Phase
Atopic Eczema Radiation: combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Assessor-blinded Study to Compare Narrowband Ultraviolet B With Combined Narrowband Ultraviolet B and Ultraviolet A1 for Atopic Eczema
Study Start Date : August 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: NB-UVB monotherapy
Narrowband ultraviolet B monotherapy will be used
Radiation: combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy
NB-UVB combined with UVA1

Active Comparator: NB-UVB + UVA1
Narrowband ultraviolet B combined with ultraviolet A1 phototherapy will be used
Radiation: combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy
NB-UVB combined with UVA1




Primary Outcome Measures :
  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 Outcome Measures :
  1. POEM (patient orientated eczema measure) [ Time Frame: 26 weeks after treatment completion ]
    patient-assessed eczema severity



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915146


Contacts
Contact: Robert S Dawe, MD, FRCP rdawe@nhs.net

Locations
United Kingdom
Ninewells Hospital Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Robert S Dawe, MD, FRCP         
Sponsors and Collaborators
University of Dundee
NHS Tayside
Investigators
Principal Investigator: Robert S Dawe NHS Tayside and University of Dundee

Responsible Party: Robert Dawe, Dr., University of Dundee
ClinicalTrials.gov Identifier: NCT02915146     History of Changes
Other Study ID Numbers: 2015DS04
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Robert Dawe, University of Dundee:
eczema
phototherapy
uva1
uvb
adults
children

Additional relevant MeSH terms:
Eczema
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases