Condition category
Skin and Connective Tissue Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/11/2014
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 Sarah Wakelin

ORCID ID

Contact details

Department of Dermatology
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom
+44 (0)20 7886 1194

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0241117754

Study information

Scientific title

Acronym

Study hypothesis

To investigate whether the normal delayed-type contact allergic reaction to a known contact allergen, in this case nickel, can be prevented by pretreating the skin to be tested with topical tacrolimus, as an immunomodulator.

Ethics approval

Not provided at time of registration

Study design

Single-blinded vehicle-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Skin and Connective Tissue Diseases: Nickel allergy

Intervention

Patients will pre-treat an area on one upper arm with topical tacrolimus ointment for 1 week and simultaneously they will treat a similar area on the opposite upper arm with vehicle in ointment form. Identical patches of a series of nickel dilutions will be applied to both topically treated areas. These patches will be removed 48 h later and readings of the tested areas will be performed and any positive results graded according to the European Contact Dermatitis Group criteria.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The patch test results will be assessed visually and a record will be made of whether topical tacrolimus has prevented a delayed-type hypersensitivity reaction, when compared to the vehicle treated area tested, and if so at which nickel concentrations.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2002

Overall trial end date

01/11/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

10-20 patients.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2002

Recruitment end date

01/11/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Dermatology
London
W2 1NY
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

St Mary's 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