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

This study has been completed.
Sponsor:
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00317681
First received: April 21, 2006
Last updated: September 7, 2007
Last verified: September 2007

April 21, 2006
September 7, 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 ClinicalTrials.gov 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00317681
AMG 001, 2004-005020-41
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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