Varicose eczema
Conditions
Interventions
Trade Name: Protopic
Product Name: Protopic 0.1% tacrolimus
Pharmaceutical Form: Ointment
Sponsors
Craigavon Area Hospital Group Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent A confirmed clinical diagnosis of varicose eczema Age 18 or over Male or female 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with any other skin disease that may interfere with disease assessments. Patients who have a severe concurrent disease. Patients who have a known intolerance to any of the constituents of the medications. Treatment with systemic therapies in the four weeks prior to and during the study Treatment with any topical therapies to site with active varicose eczema within one week of entry into the study except emollient therapy Women who are not post- menopausal for at least a year, surgical sterile, or established on oral contraception or contraceptive methods of equivalent efficacy for one month before and during study. Females who are pregnant, breastfeeding or planning a pregnancy. Patients who have participated in a clinical trial in the previous three months. Patients who in the Investigator's opinion have a clinically significant medical or psychiatric condition which may compromise the patient's adherence to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effeicacy of tacrolimus ointment 0.1% in the treatment of varicose eczema. ;Secondary Objective: To evaluate the safety of tacrolimus ointment 0.1% in the treatment of varicose eczema;Primary end point(s): The primary endpoint will be the difference between baseline and study completion with respect to number of active lesions. This will be measured by: Investigator's assessment of individual signs Investigator's affected area assessment Patient's assessment of itch Investigator and patient's global assessment of varicose eczema The secondary endpoint will be the analysis of the adverse events and other safety data (ie tacrolimus blood levels) that have been collated throughout the study. | — |
Countries
United Kingdom
Outcome results
None listed