Condition category
Skin and Connective Tissue Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
17/04/2015
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 R C H Yu

ORCID ID

Contact details

Dermatology Department
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263128762

Study information

Scientific title

A randomised double-blinded cross-over trial comparing betamethasone valerate and tacrolimus ointment for the treatment of moderate to severe atopic eczema

Acronym

Study hypothesis

Is tacrolimus more efficacious than betamethasone valerate ointment in moderate to severe atopic dermatitis?

Ethics approval

Not provided at time of registration

Study design

Randomised double-blinded cross-over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Skin and Connective Tissue Diseases: Atopic dermatitis

Intervention

1. Steroid ointment
2. Other ointment

Intervention type

Drug

Phase

Not Applicable

Drug names

Betamethasone valerate and tacrolimus ointment

Primary outcome measures

SCORAD score (numerical assessment score of patient symptoms, range 0-103). Ointment weight. Recording of side-effects noted.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/01/2003

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

100 patients from Dermatology

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

31/01/2003

Recruitment end date

01/10/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Middlesex Hospital
London
W1N 8AA
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

University College London Hospitals NHS Trust (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

Publication citations

Additional files

Editorial Notes