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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00317681
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : September 10, 2007
Information provided by:
Heinrich-Heine University, Duesseldorf

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 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.

Condition or disease Intervention/treatment Phase
Cutaneous Lupus Erythematosus Drug: Tacrolimus ointment Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Efficacy of Topical Tacrolimus in the Treatment of Cutaneous Lupus Erythematosus - a Multi-Center-Trial
Study Start Date : August 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Primary Outcome Measures :
  1. Difference in skin lesions of patients with CLE before (begin of study) and after treatment (end of study) evaluated by a clinical score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00317681

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Heinrich-Heine-University of Duesseldorf, Department of Dermatology
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
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Principal Investigator: Annegret Kuhn, MD Heinrich-Heine-University of Duesseldorf, Department of Dermatolgy
Layout table for additonal information Identifier: NCT00317681    
Other Study ID Numbers: AMG 001
First Posted: April 25, 2006    Key Record Dates
Last Update Posted: September 10, 2007
Last Verified: September 2007
Keywords provided by Heinrich-Heine University, Duesseldorf:
Cutaneous lupus erythematosus
Tacrolimus ointment
Topical treatment
Skin lesions
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action