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

NCT00317681 | Completed Phase 2

• 2 other identifiers: AMG 0012004-005020-41
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Lupus Erythematosus

Keywords

Cutaneous lupus erythematosus; Tacrolimus ointment; Topical treatment; Skin lesions

Outcome Measures

Primary Outcomes (1)

• Difference in skin lesions of patients with CLE before (begin of study) and after treatment (end of study) evaluated by a clinical score

Interventions

Tacrolimus ointment DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Heinrich-Heine-University of Duesseldorf, Department of Dermatology

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

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

  PMID: 14513247 BACKGROUND

• 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.

  PMID: 16547761 BACKGROUND

• 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.

  PMID: 16501922 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Annegret Kuhn, MD

  Heinrich-Heine-University of Duesseldorf, Department of Dermatolgy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 21, 2006
• First Posted: April 25, 2006
• Study Start: August 1, 2005
• Study Completion: February 1, 2007
• Last Updated: September 10, 2007

Record last verified: 2007-09

Locations

DE (1)