Cutaneous Lupus Erythematosus and Elidel

NCT00222183 | Withdrawn

• 1 other identifier: CASM-DE-08
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid

Keywords

Lupus erythematodes; Elidel; Pimecrolimus; Chronic discoid lupus erythematosus (dLE); subacute cutaneous lupus erythematosus (scLE)

Outcome Measures

Primary Outcomes (1)

• therapeutic effect

Secondary Outcomes (1)

• local tolerability

Interventions

Elidel (pimecrolimus) DRUG

Eligibility Criteria

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

You may qualify if:

• 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).
• Patients with histologically defined dLE or scLE.
• 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.
• The patients must receive a baseline medication with chloroquine.
• Patients must have been informed about the study procedures and medication and must have given their written Informed Consent.
• Patients expected to be available for the duration of the study and able to comply with the study visits.

You may not qualify if:

• Any of the following criteria will disqualify a patient from participating in this study:
• 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.
• 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.
• Patients who are receiving oral medication, known to precipitate lupus lesions (e.g. procainamide, diuretics, piroxicam, beta blockers, griseofulvin, lithium and other psychotropic drugs).
• Topical therapy \[i.e. corticosteroids, etc.\] within 2 weeks prior to first application of study medication.
• 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)
• Patients who suffer from systemic or generalized infections (bacterial, fungal, viral)
• Patients with malignancy or history of malignancy.
• 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.

Sponsors & Collaborators

• University of Leipzig: lead
• Novartis: collaborator

Study Sites (1)

Department of Dermatology, University of Leipzig

Leipzig, Saxony, 04103, Germany

Location

Related Publications (4)

• Bornhovd EC, Burgdorf WH, Wollenberg A. Immunomodulatory macrolactams for topical treatment of inflammatory skin diseases. Curr Opin Investig Drugs. 2002 May;3(5):708-12.

  PMID: 12090543 BACKGROUND

• Katsiari CG, Liossis SN, Dimopoulos AM, Charalambopoulo DV, Mavrikakis M, Sfikakis PP. CD40L overexpression on T cells and monocytes from patients with systemic lupus erythematosus is resistant to calcineurin inhibition. Lupus. 2002;11(6):370-8. doi: 10.1191/0961203302lu211oa.

  PMID: 12139375 BACKGROUND

• Wellington K, Jarvis B. Topical pimecrolimus: a review of its clinical potential in the management of atopic dermatitis. Drugs. 2002;62(5):817-40. doi: 10.2165/00003495-200262050-00007.

  PMID: 11929333 BACKGROUND

• Eichenfield LF, Lucky AW, Boguniewicz M, Langley RG, Cherill R, Marshall K, Bush C, Graeber M. Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. J Am Acad Dermatol. 2002 Apr;46(4):495-504. doi: 10.1067/mjd.2002.122187.

  PMID: 11907497 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Sticherling, Prof. Dr. med.

  University of Leipzig, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: June 1, 2003
• Last Updated: June 28, 2018

Record last verified: 2007-02

Locations

DE (1)