Contact information
Type
Scientific
Primary contact
Dr Nicholas Reynolds
ORCID ID
Contact details
Department of Dermatology
Medical School
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 222 8936
n.j.reynolds@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
94090017 R140/05081
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Double blind randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Skin and connective tissue diseases:
Intervention
1. TLO1-UVB
2. UVA
3. 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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/06/1996
Overall trial end date
30/06/1998
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients, aged 16-65 years with moderate severe atopic dermatitis.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
75
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/06/1996
Recruitment end date
30/06/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Dermatology
Newcastle upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2001 results on http://www.ncbi.nlm.nih.gov/pubmed/11438134
Publication citations
-
Results
Reynolds NJ, Franklin V, Gray JC, Diffey BL, Farr PM, Narrow-band ultraviolet B and broad-band ultraviolet A phototherapy in adult atopic eczema: a randomised controlled trial., Lancet, 2001, 357, 9273, 2012-2016, doi: 10.1016/S0140-6736(00)05114-X.