Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus

Inclusion Criteria: * A clinical and histological diagnosis of CLE (DLE, SCLE, LET) who failed to respond to topical corticosteroids; * Total RCLASI activity score of skin lesions \>6 (at least 3 points in at least 2 locations); * At least one primary but preferably 2 methods of contraception; Exclusion Criteria: * Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal involvement, requiring systemic medical treatment for the disease; * Clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; * Active severe infection diseases, including chronic or localized; * Patients with hepatic insufficiency (AST, ALT \> 2.5 x ULN), severe renal failure (creatinine clearance \< 60ml/min), or hypercholesterolemia characterized by: 1. Fasting triglyceridemia \> 1.5 x upper limit of normal (ULN) 2. Fasting total cholesterol \> 1.5 x ULN 3. Fasting low-density lipoprotein (LDL) cholesterol \> 1.5x ULN * Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil; * Patients with cardiovascular risk factors that would exclude a starting dose of 30 mg of alitretinoin; * Topical corticosteroids within 14 days prior to dosing; * Patients treated with any systemic or topical retinoids within 4 weeks before start of study treatment; * Drugs with a potential for drug-drug interaction, such as systemic tetracyclines, ketoconazole, or St. John"s Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before start of study treatment; * Initiation or change in the dose of any current systemic medication for the treatment of CLE/SLE prior to the study (time depending on drug class and half-life); * Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study; * Concomitant medication with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolbutamide; * Drugs associated to CLE-induction: terbinafine, hydrochlorothiazide, diltiazem, verapamil, nifedipine, nitrendipine, fluorouracil, penicillamine, infliximab, adalimumab, etanercept, pantoprazole; Other protocol-defined inclusion/exclusion criteria may apply