EUCTR2010-024131-16-DE进行中（未招募）不适用
Efficacy and Safety of oral Alitretinoin (Toctino®) in the Treatment of Patients with Cutaneous LupusErythematosus: A Multicentre, Open-Label, Prospective Pilot Study - AliCLE
niversitätsklinikum Münster0 个研究点目标入组 33 人开始时间: 2011年2月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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).
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