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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- therapeutic effect
Study Overview
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).
Detailed Description
Lupus erythematosus is an autoimmune disease of unknown origin which is classified according to its clinical features, the course, and laboratory findings. A rough classification divides lupus erythematosus into three subgroups:
- discoid lupus erythematosus (dLE),
- subacute cutaneous lupus erythematosus (scLE), and
- systemic lupus erythematosus (sLEsLE).
The onset of lupus erythematosus affects women three times more frequently than men, with an onset between the 20th and 40th years of life. It is often aggravated or triggered by multiple factors like UV-light, mainly UV-A, hormones (thyroid diseases), pregnancy, oral contraceptives, stress or trauma. Some medications might also play a role as triggering substances, for example antibiotics, psychotropic drugs, beta blockers, procainamide, diuretics, piroxicam, and griseofulvin.
The prevalence of systemic lupus erythematosus (sLEsLE) is 12 to 50/100.000 population worldwide, the incidence is 2 to 8/100.000 per year. Skin disease is one of the most frequent clinical complaints of patients suffering from sLEsLE. It has been found to occur in up to 70% of patients during the course of the disease.
The interesting subgroups of LE that are part of the study population suffer from discoid lupus erythematosus (dLE) or subacute cutaneous lupus erythematosus (scLE) (Fritsch, 1998).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
therapeutic effect
Secondary Outcomes
- local tolerability