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

April 21, 2006
April 25, 2006
September 10, 2007
August 2005
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Difference in skin lesions of patients with CLE before (begin of study) and after treatment (end of study) evaluated by a clinical score
Same as current
Complete list of historical versions of study NCT00317681 on Archive Site
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Efficacy of Topical Tacrolimus in Different Subtypes With Cutaneous Lupus Erythematosus (CLE)
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Cutaneous Lupus Erythematosus
Drug: Tacrolimus ointment
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2007
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
AMG 001
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Heinrich-Heine University, Duesseldorf
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Principal Investigator: Annegret Kuhn, MD Heinrich-Heine-University of Duesseldorf, Department of Dermatolgy
Heinrich-Heine University, Duesseldorf
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP