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ISRCTN
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ISRCTN10725589
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ClinicalTrials.gov identifier
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Public title
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Ultraviolet Light (UV) Therapy for Atopic Dermatitis : Double blind, randomised trial of narrow band (TLO1) versus UVA versus placebo.
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Scientific title
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Acronym
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N/A
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Serial number at source
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94090017 R140/05081
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Study hypothesis
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There is a need for safe alternative therapies to emollients and topical steroids in atopic dermatitis. Recent non-blinded studies suggest that ultraviolet A (UVA) and narrow band width UVB (TLO1) phototherapy may be effective in atopic dermatitis. We propose to study 75 adult patients, age 16-65 years with moderate severe atopic dermatitis.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Skin and connective tissue diseases: Skin and connective tissue diseases
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Participants - inclusion criteria
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Patients, aged 16-65 years with moderate severe atopic dermatitis.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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30/06/1996
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Anticipated end date
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30/06/1998
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Status of trial
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Completed
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Patient information material
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Target number of participants
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75
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Interventions
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Patients will be randomly allocated to receive
i. TLO1-UVB
ii. UVA
iii. Placebo phototherapy.
Initial dose of UVA will be 5 J/sq cm, increased to 10 then 15 J/sq cm as tolerated. Initial dose of TLO1 will be increased from 0.4, to 0.6, to 0.9, to 1.2 J/sq cm until mild erythema develops and then according to a defined protocol. Visible fluorescent lamps will be employed for placebo treatments. Treatments will be twice weekly for a maximum of 24 exposures.
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Primary outcome measure(s)
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Preliminary work suggests a response should be detectable after 12 treatments. Physical signs of disease activity, overall extent of disease, patient symptoms and quantities of topical steroids used will be assessed, by an observer who is unaware of treatment received, at baseline, after 6, 12, 18 and 24 treatments and 3 months after stopping phototherapy.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive Northern and Yorkshire
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Trial website
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Publications
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Contact name
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Dr
Nicholas
Reynolds
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Address
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Department of Dermatology
Medical School
Framlington Place
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE2 4HH
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Country
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United Kingdom
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Tel
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+44 (0)191 222 8936
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Fax
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+44 (0)191 222 7094
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Email
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n.j.reynolds@ncl.ac.uk
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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28/12/2006
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Date ISRCTN assigned
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23/01/2004
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