Clinical trial NCT00317681: Efficacy of Topical Tacrolimus in Different Subtypes With Cutaneous Lupus Erythematosus (CLE)
Official title: The Efficacy of Topical Tacrolimus in the Treatment of Cutaneous Lupus Erythematosus - a Multi-Center-Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous Lupus Erythematosus
Keywords: Cutaneous lupus erythematosus
Tacrolimus ointment
Topical treatment
Skin lesions
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2006-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Difference in skin lesions of patients with CLE before (begin of study) and after treatment (end of study) evaluated by a clinical score
Secondary outcomes:
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Heinrich-Heine-University of Duesseldorf, Department of Dermatology
state: NRW
Study officials:
affiliation: Heinrich-Heine-University of Duesseldorf, Department of Dermatolgy
name: Annegret Kuhn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.