CompletedPhase 2

Efficacy of Topical Tacrolimus in Different Subtypes With Cutaneous Lupus Erythematosus (CLE)

Germany30 participantsStarted 2005-08

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Difference in skin lesions of patients with CLE before (begin of study) and after treatment (end of study) evaluated by a clinical score

Trial details

NCT IDNCT00317681

SponsorHeinrich-Heine University, Duesseldorf

Sponsor typeOTHER

Study typeINTERVENTIONAL

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