Cutaneous Lupus Erythematosus Clinical Trial
Official title:
The Efficacy of Topical Tacrolimus in the Treatment of Cutaneous Lupus Erythematosus - a Multi-Center-Trial
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 role in the pathogenesis of lupus erythematosus. Tacrolimus targets T lymphocytes and suppresses their activation by inhibiting the expression of cytokine genes, such as IL-2. Therefore, treatment of cutaneous lupus erythematosus with topical tacrolimus might result in an improvement of skin lesions in such patients.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Heinrich-Heine-University of Duesseldorf, Department of Dermatology | Duesseldorf | NRW |
Lead Sponsor | Collaborator |
---|---|
Heinrich-Heine University, Duesseldorf |
Germany,
Bacman D, Tanbajewa A, Megahed M, Ruzicka T, Kuhn A. [Topical treatment with tacrolimus in lupus erythematosus tumidus]. Hautarzt. 2003 Oct;54(10):977-9. German. — View Citation
Kuhn A, Gensch K, Ständer S, Bonsmann G. [Cutaneous lupus erythematosus. Part 1: clinical manifestations and classification]. Hautarzt. 2006 Mar;57(3):251-67; quiz 268. German. — View Citation
Kuhn A, Gensch K, Ständer S, Bonsmann G. [Cutaneous lupus erythematosus. Part 2: diagnostics and therapy]. Hautarzt. 2006 Apr;57(4):345-8; quiz 359. German. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in skin lesions of patients with CLE before (begin of study) and after treatment (end of study) evaluated by a clinical score |
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