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

Cutaneous Lupus Erythematosus Clinical Trial

Official title:

The Efficacy of Topical Tacrolimus in the Treatment of Cutaneous Lupus Erythematosus - a Multi-Center-Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317681
• Other study ID #: AMG 001
• Secondary ID: 2004-005020-41
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2006
• Last updated: September 7, 2007
• Start date: August 2005
• Est. completion date: February 2007

Study information

• Verified date: September 2007
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Lupus Erythematosus
• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic

Intervention

Drug:
• Tacrolimus ointment

Locations

Country	Name	City	State
Germany	Heinrich-Heine-University of Duesseldorf, Department of Dermatology	Duesseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. German. — View Citation

Kuhn A, Gensch K, Ständer S, Bonsmann G. [Cutaneous lupus erythematosus. Part 1: clinical manifestations and classification]. Hautarzt. 2006 Mar;57(3):251-67; quiz 268. German. — View Citation

Kuhn A, Gensch K, Ständer S, Bonsmann G. [Cutaneous lupus erythematosus. Part 2: diagnostics and therapy]. Hautarzt. 2006 Apr;57(4):345-8; quiz 359. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in skin lesions of patients with CLE before (begin of study) and after treatment (end of study) evaluated by a clinical score