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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heinrich-Heine University, Duesseldorf
• Treatments: Tacrolimus

Criteria

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