An open label pilot study to evaluate the efficacy and safety of topical tacrolimus 0l1% (Protopic) in the treatment of varicose eczema

Phase 1

• Conditions: Varicose eczema

• Registration Number: EUCTR2004-004467-29-GB
• Lead Sponsor: Craigavon Area Hospital Group Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-11
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified