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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list