Condition category
Skin and Connective Tissue Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
15/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2001 results on http://www.ncbi.nlm.nih.gov/pubmed/11438134

Publication citations

  1. 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.

Additional files

Editorial Notes