Efficacy and Safety of oral Alitretinoin (Toctino®) in the Treatment of Patients with Cutaneous LupusErythematosus: A Multicentre, Open-Label, Prospective Pilot Study
- Conditions
- Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]?dult subjects of any ethnicity and either gender with Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of alitretinoin (30 mg per day) in the treatment of Cutaneous Lupus Erythematosus lesions.MedDRA version: 16.0Level: PTClassification code 10056509Term: Cutaneous lupus erythematosusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
- Registration Number
- EUCTR2010-024131-16-DE
- Lead Sponsor
- niversitätsklinikum Münster
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 33
1. Patients of any gender aged from 18 to 75 years;
2. A clinical and histological diagnosis of CLE (DLE, SCLE, LET without major systemic involvement) who
failed to response to topical corticosteroids;
3. Total RCLASI activity score of >6 (at least 3 points in at least 2 locations) on an assessment of erythema, scale/
hyperkeratosis, edema/infiltration and subcutaneous nodule/plaque of the lesion (mucous membrane lesions/
alopecia excluded);
4. Women of childbearing potential must agree to use at least one primary method of contraception but preferably
2 methods of contraception under supervision of the investigator or a gynecologist
5. Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3
1. Patients unable to comply with the requirements of the study;
2. Only scarred cutaneous target lesions without activity;
3. Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal
involvement, requiring systemic medical treatment for the disease;
4. Active skin disease other than CLE or another progressive or serious disease that interferes with the study
outcome;
5. Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks
before and during the study;
6. Active severe infection diseases, including chronic or localized;
7. Patients with hepatic insufficiency, severe renal failure, or uncontrolled hypercholesterinemia, uncontrolled as
characterized by:
i. Fasting triglyceridemia > 1.5 x upper limit of normal (ULN)
ii. Fasting cholesterol > 1.5 x ULN
iii. Fasting low-density lipoprotein (LDL) cholesterol > 1.5x ULN
8. 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;
9. Patients with hypothyroidism or hypervitaminosis A;
10. Patients with cardiovascular risk factors that would exclude a starting dose of 30 mg of alitretinoin;
11. Topical corticosteroids within 14 days prior to dosing;
12. Patients treated with any systemic or topical retinoids within 4 weeks before start of study treatment;
13. Patients receiving 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;
14. 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);
15. Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study;
16. Concomitant treatment with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin,
thiazides, furosemide, sulfonamides or tolebutamide;
17. Drugs associated to CLE-induction: terbinafine, hydrochlorothiazide, diltiazem, verapamil, nifedipine,
nitrendipine, fluorouracil, penicillamine, infliximab, adalimumab, etanercept, pantoprazole;
18. Participation in another clinical trial including the four week period preceding the study or having received a
non-licensed drug within the last 3 months prior to the study;
19. Pregnancy (according to pregnancy test) or nursing.
20. Patients with hereditary myopathy in patient and family history;
21. Patients with known rhabdomyolysis in patient history (e.g. musculous-toxic complications in association with statin and fibrate therapy).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method