Condition category
Skin and Connective Tissue Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
21/04/2008
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 Peter Arkwright

ORCID ID

Contact details

Child Health
Booth Hall Children's Hospital
Charlestown Road
Blackley
Manchester
M9 7AA
United Kingdom
+44 0161 220 5535
peter.arkwright@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0129118582

Study information

Scientific title

Acronym

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

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

Phase

Not Specified

Drug names

Protopic

Primary outcome measures

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 trial start date

01/11/2002

Overall trial end date

01/11/2004

Reason abandoned

Eligibility

Participant inclusion criteria

50 children

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

50

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

United Kingdom

Trial participating centre

Child Health
Manchester
M9 7AA
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Central Manchester and Manchester Children's University 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

Results in http://www.ncbi.nlm.nih.gov/pubmed/17342794

Publication citations

  1. Results

    Arkwright PD, Gillespie MC, Ewing CI, David TJ, Blinded side-to-side comparison of topical corticosteroid and tacrolimus ointment in children with moderate to severe atopic dermatitis., Clin. Exp. Dermatol., 2007, 32, 2, 145-147.

Additional files

Editorial Notes