Status:
COMPLETED
Efficacy of Topical Tacrolimus in Different Subtypes With Cutaneous Lupus Erythematosus (CLE)
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Cutaneous Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of topical tacrolimus in different subtypes of cutaneous lupus erythematosus. As shown by several groups activated memory T lymphocytes play a key...
Detailed Description
In patients with cutaneous lupus erythematosus (CLE), topical corticosteroids are the mainstay of treatment; however, a long-term use can lead to numerous side effects including skin atrophy. Recently...
Eligibility Criteria
Inclusion
- Cutaneous lupus erythematosus confirmed by histological analysis
- Topical use of glucocorticosteroids stopped at least two weeks before the start of the study
- Presence of two primary skin lesions with a clinical score ≥ 1
- Written informed consent available prior to any screening procedures
Exclusion
- Systemic medication if taken for lupus erythematosus (e.g. chloroquine or hydroxychloroquine) started at least 6 months prior to the beginning of the study
- Women of childbearing potential using inadequate birth control measures
- Pregnancy and lactation
- Known hypersensitivity to tacrolimus or any of the excipients
- Patients receiving systemic immunosuppressive drugs and cytotoxic agents other than antimalarial agents
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00317681
Start Date
August 1 2005
End Date
February 1 2007
Last Update
September 10 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Heinrich-Heine-University of Duesseldorf, Department of Dermatology
Düsseldorf, North Rhine-Westphalia, Germany, 40225