EUCTR2004-004467-29-GB
Active, not recruiting
Phase 1
An open label pilot study to evaluate the efficacy and safety of topical tacrolimus 0l1% (Protopic) in the treatment of varicose eczema
Craigavon Area Hospital Group Trust0 sites12 target enrollmentJuly 11, 2005
DrugsProtopic
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Craigavon Area Hospital Group Trust
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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