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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
History of Changes
  Purpose

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 Intervention Phase
Cutaneous Lupus Erythematosus
 Drug: Tacrolimus ointment
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Efficacy of Topical Tacrolimus in the Treatment of Cutaneous Lupus Erythematosus - a Multi-Center-Trial

Resource links provided by NLM:

Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by Heinrich-Heine University, Duesseldorf:

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

Estimated Enrollment: 30
Study Start Date: August 2005
Study Completion Date: February 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317681

Locations
Germany
Heinrich-Heine-University of Duesseldorf, Department of Dermatology
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Annegret Kuhn, MD Heinrich-Heine-University of Duesseldorf, Department of Dermatolgy
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00317681     History of Changes
Other Study ID Numbers: AMG 001, 2004-005020-41
Study First Received: April 21, 2006
Last Updated: September 7, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heinrich-Heine University, Duesseldorf:
Cutaneous lupus erythematosus
Tacrolimus ointment
Topical treatment
Skin lesions

Additional relevant MeSH terms:
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Skin Diseases
Autoimmune Diseases
Immune System Diseases
 Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013