A study to investigate whether topical tacrolimus can prevent delayed-type hypersensitivity to nickel in patients with known nickel contact allergy

ISRCTN ISRCTN34213833
DOI https://doi.org/10.1186/ISRCTN34213833
Secondary identifying numbers N0241117754
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
03/01/2020
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
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sarah Wakelin
Scientific

Department of Dermatology
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom

Phone +44 (0)20 7886 1194
Email hf@cct.com

Study information

Study designSingle-blinded vehicle-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific titleThe effect of topical tacrolimus on nickel contact dermatitis elicitation reactions
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSkin and Connective Tissue Diseases: Nickel allergy
InterventionPatients 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 typeOther
Primary outcome measureThe 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 measuresNot provided at time of registration
Overall study start date01/11/2002
Completion date01/11/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants10-20 patients.
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/2002
Date of final enrolment01/11/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Dermatology
London
W2 1NY
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

St Mary's NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
2003 results in: https://doi.org/10.1046/j.1365-2133.149.s64.9.x (added 03/01/2020)
IPD sharing plan

Editorial Notes

03/01/2020: The following changes have been made:
1. Publication reference added to publication and dissemination plan.
2. The scientific title has been added from the reference.