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

NCT ID: NCT00317681

Last Updated: 2007-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cutaneous Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tacrolimus ointment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Principal Investigators

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Annegret Kuhn, MD

Role: PRINCIPAL_INVESTIGATOR

Heinrich-Heine-University of Duesseldorf, Department of Dermatolgy

Locations

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Heinrich-Heine-University of Duesseldorf, Department of Dermatology

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1007/s00105-003-0593-3. No abstract available. German.

Reference Type BACKGROUND
PMID: 14513247 (View on PubMed)

Kuhn A, Gensch K, Stander S, Bonsmann G. [Cutaneous lupus erythematosus. Part 2: diagnostics and therapy]. Hautarzt. 2006 Apr;57(4):345-8; quiz 359. doi: 10.1007/s00105-006-1138-3. German.

Reference Type BACKGROUND
PMID: 16547761 (View on PubMed)

Kuhn A, Gensch K, Stander S, Bonsmann G. [Cutaneous lupus erythematosus. Part 1: clinical manifestations and classification]. Hautarzt. 2006 Mar;57(3):251-67; quiz 268. doi: 10.1007/s00105-006-1094-y. German.

Reference Type BACKGROUND
PMID: 16501922 (View on PubMed)

Other Identifiers

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2004-005020-41

Identifier Type: -

Identifier Source: secondary_id

AMG 001

Identifier Type: -

Identifier Source: org_study_id