| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN10725589 |
| Date ISRCTN assigned | 23/01/2004 |
| Local reference number(s) | 94090017 R140/05081 |
| Public title | Ultraviolet Light (UV) Therapy for Atopic Dermatitis : Double blind, randomised trial of narrow band (TLO1) versus UVA versus placebo. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Skin and connective tissue diseases: Skin and connective tissue diseases |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients, aged 16-65 years with moderate severe atopic dermatitis. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 30/06/1996 |
| Anticipated end date | 30/06/1998 |
| Status of trial | Completed |
| Target number of participants | 75 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | NHS Executive Northern and Yorkshire |
| Sponsor name | NHS R&D Regional Programme Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Dr Nicholas Reynolds |
| Contact details | Department of Dermatology
Medical School
Framlington Place
Newcastle upon Tyne
United Kingdom
NE2 4HH |
| Contact telephone | +44 (0)191 222 8936 |
| Contact fax | +44 (0)191 222 7094 |
| Contact email | n.j.reynolds@ncl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN10725589 |
| Date last extracted from ISRCTN register | 17/04/2008 |
