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
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