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):
- 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:
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.
- Patients with a history of drug or alcohol abuse during the past 1 year.
- 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).
- Patients who have received an investigational drug within 4 weeks prior to the first application of the study medication.
- Patients who are unwilling or unable to provide Informed Consent or to participate satisfactorily for the entire trial period.
- Any other condition which, in the opinion of the investigator, would render the patient ineligible for the study.