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 |
| Protocol serial number | N0241117754 |
| Sponsor | Department of Health (UK) |
| Funder | St Mary's NHS Trust (UK) |
- 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
Scientific
Department of Dermatology
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom
| Phone | +44 (0)20 7886 1194 |
|---|---|
| hf@cct.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blinded vehicle-controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| 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
- United Kingdom
- England
Study participating centre
Department of Dermatology
London
W2 1NY
United Kingdom
W2 1NY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| 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.
