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

Sponsor

Heinrich-Heine University, Duesseldorf (Other)

Overall Status

Completed

CT.gov ID

NCT00317681

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2005

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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