Ultraviolet Light (UV) Therapy for Atopic Dermatitis: Double blind, randomised trial of narrow band (TLO1) versus UVA versus placebo.

ISRCTN	ISRCTN10725589
DOI	https://doi.org/10.1186/ISRCTN10725589
Secondary identifying numbers	94090017 R140/05081

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 15/12/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nicholas Reynolds
Scientific

Department of Dermatology
Medical School
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom

Phone	+44 (0)191 222 8936
Email	n.j.reynolds@ncl.ac.uk

Study information

Study design	Double blind randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	30/06/1996
Completion date	30/06/1998

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	75
Key inclusion criteria	Patients, aged 16-65 years with moderate severe atopic dermatitis.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	30/06/1996
Date of final enrolment	30/06/1998

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Dermatology

Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/06/2001		Yes	No