Cutaneous Lupus Erythematosus and Elidel

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by University of Leipzig.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00222183
First received: September 19, 2005
Last updated: April 5, 2007
Last verified: February 2007
  Purpose

This trial evaluates the therapeutic effect of Elidel (pimecrolimus) in comparison to the corresponding vehicle in patients with chronic discoid lupus erythematosus (dLE) or subacute cutaneous lupus erythematosus (scLE).


Condition Intervention
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Drug: Elidel (pimecrolimus)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of the Therapeutic Effect and Local Tolerability of Elidel® Cream 1% (Pimecrolimus) in Chronic Discoid Lupus Erythematosus (dLE) or Subacute Cutaneous Lupus Erythematosus (scLE)

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • therapeutic effect

Secondary Outcome Measures:
  • local tolerability

Estimated Enrollment: 25
Study Start Date: June 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects may be included only if they fulfil the following inclusion criteria on the pre-treatment days (between Day -14 and Day -2) and on Day 1 (before first application of study medication):

  1. Female and male patients aged 18-65 years (females of childbearing potential may be enrolled provided they are routinely using adequate contraception in the assessment of the investigator).
  2. Patients with histologically defined dLE or scLE.
  3. The test sites (lupus erythematosus plaques) must be on the face only, and have a total sign score of 4 or more (sum of erythema, induration and scaling scores) and must be the same within a given patient (ie not differing in the sum for erythema, induration or scaling). Each of the 2 test sites must be at least 3 cm apart.
  4. The patients must receive a baseline medication with chloroquine.
  5. Patients must have been informed about the study procedures and medication and must have given their written Informed Consent.
  6. Patients expected to be available for the duration of the study and able to comply with the study visits.

Exclusion Criteria:

Any of the following criteria will disqualify a patient from participating in this study:

  1. Systemic therapy for lupus erythematosus within one month prior to first application of study medication in this study (steroids, retinoids, herbal medicines, etc) except chloroquine.
  2. Patients with systemic lupus erythematosus or patients whose chronic discoid lupus erythematosus appears to be spontaneously flaring or improving based on the experience of the investigator.
  3. Patients who are receiving oral medication, known to precipitate lupus lesions (e.g. procainamide, diuretics, piroxicam, beta blockers, griseofulvin, lithium and other psychotropic drugs).
  4. Topical therapy [i.e. corticosteroids, etc.] within 2 weeks prior to first application of study medication.
  5. Patients with clinically significant medical conditions which could interfere with the conduct of the study. This includes:

    • Renal impairment (creatinine > 2.0 mg/dl)
    • Hepatic impairment (liver function test values above notable abnormalities; g-GT, ALAT, ASAT: 2x the upper limit)
    • Haematologic disorders (haemoglobin, platelet, erythrocyte and leukocyte counts above notable abnormalities)
    • Neurologic disorders (significant impairment of sensory and motor function as judged by the investigator)
    • Patients known to be previously immunocompromised (e.g. lymphoma, AIDS, myelodysplastic disorders) or treated recently with immunosuppressive drugs or treatment (e.g. radiation therapy or chemotherapy). HIV tests are not necessary.
    • Patients with clinically relevant cardio-vascular diseases (New York Heart Association [NYHA] III or IV)
  6. Patients who suffer from systemic or generalized infections (bacterial, fungal, viral)
  7. Patients with malignancy or history of malignancy.
  8. Patients who suffer from acute or chronic bacterial, viral, or fungal skin diseases. However, patients with tinea pedum and/or onychomycosis can be included. Likewise, only patients with acute herpes lesions are excluded.
  9. Patients with a history of drug or alcohol abuse during the past 1 year.
  10. Patients with known hypersensitivity to any of the ingredients of the study medication or to tacrolimus (the investigator will be provided with a list of ingredients of the study medication).
  11. Patients who have received an investigational drug within 4 weeks prior to the first application of the study medication.
  12. Patients who are unwilling or unable to provide Informed Consent or to participate satisfactorily for the entire trial period.
  13. Any other condition which, in the opinion of the investigator, would render the patient ineligible for the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222183

Contacts
Contact: Michael Sticherling, Prof. Dr. med. +493419718720 sticm@medizin.uni-leipzig.de
Contact: Christina Rogalski, Dr. med. +493419718616 christina.rogalski@medizin.uni-leipzig.de

Locations
Germany
Department of Dermatology, University of Leipzig Recruiting
Leipzig, Saxony, Germany, 04103
Sub-Investigator: Christina Rogalski, Dr. med.         
Principal Investigator: Michael Sticherling, Prof. Dr. med.         
Sponsors and Collaborators
University of Leipzig
Novartis
Investigators
Principal Investigator: Michael Sticherling, Prof. Dr. med. University of Leipzig, Department of Dermatology
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00222183     History of Changes
Other Study ID Numbers: CASM-DE-08
Study First Received: September 19, 2005
Last Updated: April 5, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
Lupus erythematodes
Elidel
Pimecrolimus
Chronic discoid lupus erythematosus (dLE)
subacute cutaneous lupus erythematosus (scLE)

Additional relevant MeSH terms:
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Pimecrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 25, 2014