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

Overview

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.

Full Title of Study: “The Efficacy of Topical Tacrolimus in the Treatment of Cutaneous Lupus Erythematosus – a Multi-Center-Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double

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, topical tacrolimus has been suggested to be effective in patients with different manifestations of CLE as single or additive therapy. Its anti-inflammatory effect can be explained by inhibition of calcineurin and suppression of proinflammatory cytokines such as interleukins-2, -3, -4, granulocyte colony-stimulating factor, and tumour necrosis factor alpha. In this study, we evaluate the efficacy of tacrolimus in 30 patients with different forms of CLE (ACLE, SCLE, DLE, LET). During a period of 3 months tacrolimus ointment and its placebo are applied on two separate skin lesions. Clinical follow-up examinations including photo documentation are performed every 4 weeks.

Interventions

  • Drug: Tacrolimus ointment

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heinrich-Heine University, Duesseldorf
  • Overall Official(s)
    • Annegret Kuhn, MD, Principal Investigator, Heinrich-Heine-University of Duesseldorf, Department of Dermatolgy

References

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. doi: 10.1007/s00105-003-0593-3. No abstract available. German.

Kuhn A, Gensch K, Stander S, Bonsmann G. [Cutaneous lupus erythematosus. Part 2: diagnostics and therapy]. Hautarzt. 2006 Apr;57(4):345-8; quiz 359. doi: 10.1007/s00105-006-1138-3. German.

Kuhn A, Gensch K, Stander S, Bonsmann G. [Cutaneous lupus erythematosus. Part 1: clinical manifestations and classification]. Hautarzt. 2006 Mar;57(3):251-67; quiz 268. doi: 10.1007/s00105-006-1094-y. German.

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