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 design	Single-blinded vehicle-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title	The effect of topical tacrolimus on nickel contact dermatitis elicitation reactions
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/11/2002
Completion date	01/11/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	10-20 patients.
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/11/2002
Date of final enrolment	01/11/2003

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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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.