Status:
TERMINATED
Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Basilea Pharmaceutica International Ltd
Conditions:
Lupus Erythematosus, Cutaneous
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index...
Eligibility Criteria
Inclusion
- 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
- 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:
- Fasting triglyceridemia \> 1.5 x upper limit of normal (ULN)
- Fasting total cholesterol \> 1.5 x ULN
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01407679
Start Date
August 1 2011
End Date
April 1 2014
Last Update
June 1 2016
Active Locations (3)
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1
Department of Dematology, University Hospital
Mannheim, Baden-Wurttemberg, Germany, 68167
2
Department of Dermatology, Ludwig-Maximilians University
Munich, Bavaria, Germany, 80337
3
Department of Dermatology, University Hospital
Münster, Westfalen, Germany, 48149