contact allergy
Conditions
Interventions
Trade Name: Protopic
Product Name: Protopic (Tacrolimus)
Pharmaceutical Form: Ointment
Pharmaceutical form of the placebo: Ointment
Rout
Sponsors
NHS Lothian - University Hospitals Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. subjects will be healthy, have a diagnosis of nickel sensitivity and be aged eighteen and above. 2. subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. 3. women of childbearing potential must use an acceptable method of birth control throughout the study and have a negative urine pregnancy test prior to study entry. 4. Subjects should not receive vaccinations during the study or 14 days before or after the study. In case of live attenuated vaccination, this period should be extended to 28 days before or after the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female subjects who are pregnant, breast-feeding or planning a pregnancy within the following three months. 2. Subjects currently receiving immunosuppressive drugs. 3. Patients who have a severe concurrent disease. 4. Subjects who have had a previous reaction to tacrolimus or its constituents. 5. Treatment with systemic or topical therapies in the four weeks prior to and during the study, to include steroids, retinoids or PUVA or any other drug which may affect the study results. 6. Patient is simultaneously participating in any other clinical trial, or has participated in any other clinical trial within the past three months. 7. Any form of substance abuse (including drug or alcohol abuse) psychiatric disorder or condition which, in the opinion of the investigator, may invalidate communication with the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether tacrolimus ointment 0.1% modifies patch test responses;Secondary Objective: n/a; Primary end point(s): The objective is to assess the effects of tacrolimus ointment 0.1% with vehicle ointment base on patch test reaction. Primary endpoint: To assess what effect tacrolimuis ointment has on patch test reactions and how long ant effects persist. Safety data will be gathered throughout by the collection of adverse events. | — |
Countries
United Kingdom
Outcome results
None listed