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

Heinrich-Heine University, Duesseldorf

Status and phase

Completed

Phase 2

Conditions

Cutaneous Lupus Erythematosus

Treatments

Drug: Tacrolimus ointment

Study type

Interventional

Funder types

Other

Identifiers

NCT00317681

2004-005020-41

AMG 001

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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