Side by side comparison of 0.03% tacrolimus ointment (Protopic) versus usual topical steroid treatment in children with atopic dermatitis

ISRCTN	ISRCTN65507338
DOI	https://doi.org/10.1186/ISRCTN65507338
Secondary identifying numbers	N0129118582

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 21/04/2008

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

Not provided at time of registration

Contact information

Dr Peter Arkwright
Scientific

Child Health
Booth Hall Children's Hospital
Charlestown Road
Blackley
Manchester
M9 7AA
United Kingdom

Phone	+44 0161 220 5535
Email	peter.arkwright@manchester.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study hypothesis	In children with moderately severe atopic dermatitis is Protopic more effective than the usual steroid ointment in controlling disease activity? There is only limited information concerning the relative efficacy of topical tacrolimus versus topical corticosteroids in the treatment of atopic dermatitis in children. The aim of this study was to determine the usefulness of tacrolimus ointment in the treatment of children with moderately severe atopic dermatitis currently receiving topical corticosteroids.
Ethics approval(s)	Not provided at time of registration
Condition	Skin and Connective Tissue Diseases: Atopic dermatitis
Intervention	Randomised controlled trial with random allocation to: [A] Protopic and [B] usual steroid ointment. Fifty children attending the regional eczema referral outpatient clinic at Booth Hall Children's Hospital will be randomised to apply Protopic ointment to one arm or leg and the effectiveness of this treatment will be compared with continuing application of the usual steroid to the other limb. The doctor, who will be blinded to which side the Protopic is applied, will assess the patient 1 week later to determine which treatment is more effective.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Protopic
Primary outcome measure	Comparison of the severity of eczema on the side to which the Protopic is applied compared with the other limb.
Secondary outcome measures	Atopic dermatitis
Overall study start date	01/11/2002
Overall study end date	01/11/2004

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Not Specified
Target number of participants	50
Participant inclusion criteria	50 children
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	01/11/2002
Recruitment end date	01/11/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Child Health

Manchester
M9 7AA
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Central Manchester and Manchester Children's University Hospitals NHS Trust (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	01/03/2007		Yes	No