Cutaneous Lupus Erythematosus and Elidel (NCT00222183) | Clinical Trial Compass
WithdrawnNot Applicable
Cutaneous Lupus Erythematosus and Elidel
Stopped: Head of the study has left the institution. Study never started.
Germany0Started 2003-06
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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:
✕. 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.