Efficacy of Topical Tacrolimus in Different Subtypes With... | NCT00317681

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

NCT00317681

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Completed

Last Update Posted

Sep 10, 2007Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Cutaneous Lupus Erythematosus

Interventions

Tacrolimus ointment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2004-005020-41

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Not provided

Completion Date

Feb 2007Actual

First Submitted Date

Apr 21, 2006

First Submission Date that Met QC Criteria

Apr 21, 2006

First Posted Date

Apr 25, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2007

Last Update Posted Date

Sep 10, 2007Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus ointment	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annegret Kuhn, MD	Heinrich-Heine-University of Duesseldorf, Department of Dermatolgy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heinrich-Heine-University of Duesseldorf, Department of Dermatology		Düsseldorf	North Rhine-Westphalia	40225	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14513247	Background	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.
16547761	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.

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases