A double-blind, randomized, parallel, multicenter, vehicle-controlled, left/right paired comparison to study the efficacy, safety and tolerability of 1% LAS 37779 cream administered once and twice daily topically during 4 weeks in patients with chronic plaque psoriasis.

Almirall Prodesfarma S.A.0 个研究点目标入组 0 人开始时间: 2005年8月26日最近更新: 2020年3月30日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

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. Males and non-pregnant, non-lactating females aged 18 to 65 years, both inclusive. Women of childbearing potential are allowed to enter the trial ONLY if they use medically approved (i.e., mechanical or pharmacological ) contraceptive measures. A female is considered to be of childbearing potential unless she is hysterectomised or at least one year post-menopausal or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test at screening visit.
•2. Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them.
•3. Patients with a confirmed clinical diagnosis of stable plaque (or vulgaris) psoriasis comprising between 3 % and 30 % of body surface area, provided there are two comparable symmetrical bilateral areas between 20 and 200 cm2.
•4. Patients with a comparable baseline Total Sign Score (sum score for erythema, induration and scaling) of at least 6 of 12 for each of the treated areas.
•5. Patients in good general condition as confirmed by medical history, physical examination, vital signs measurements, ECG recording and laboratory testing.
•6. Patients not willing to use antipsoriatic therapies for the duration of the trial, except for emollients used outside the treated areas.
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Patients with pustular, erythrodermic, exfoliative, inverse or guttate psoriasis and/or psoriatic arthritis.
•2. Patients with spontaneously/rapidly improving or rapidly deteriorating plaque psoriasis.
•3. Patients who have received phototherapy, photochemical (PUVA) therapy or systemic antipsoriatic therapy, such as, but not limited to, corticosteroids, retinoids, vitamin D3 analogues, or immunosuppressive agents (methotrexate, cyclosporine) within 4 weeks before the first trial treatment at Visit 1.
•4. Patients who have received any topical antipsoriatic agents such as, but not limited to, corticosteroids, vitamin D3 analogues, salicylates, anthralin, and emollients, within the 2 weeks before the first trial treatment at Visit 1. Use of emollients outside the target lesions will be permitted, provided that the concentration, frequency and quantity throughout the trial are kept similar to those used prior to trial entry.
•5. Patients who have received any research medication within the 8 weeks before trial entry at the Screening Visit.
•6. Patients under treatment with drugs that might worsen psoriasis, such as lithium or beta-adrenergic antagonists.
•7. Patients who have received prolonged sun exposure of the target lesions within 4 weeks before the first trial treatment at Visit 1 or who intend to have prolonged sun exposure of the target lesions during the trial, which is likely to modify the subject’s disease.
•8. Patients with a history of opportunistic infections, including skin infections, that might interfere with the trial objectives within 6 months prior to the Screening Visit.
•9. Patients who have known clinically significant abnormal hepatic and/or renal function.
•10. Patients known to be hypersensitive to the trial medication or any of its components.
•11. Patients with disease states or physical conditions that would impair evaluation of the test therapy. Such disease states include, but are not limited to, AIDS or infection with HIV, and autoimmune diseases.
•12. Patients with any serious or uncontrolled physical or mental dysfunction at the discretion of the investigator which could place the patient at higher risk derived from his/her participation into the trial, could confound the results of it or is likely to prevent the patient from complying with the requirements of the trial or completing the treatment period.
•13. Patients with a history of drug abuse or continuous alcohol consumption that may prevent compliance with trial procedures.
•14. Patients unlikely to be co-operative, to take their medication, to complete their Diary Card or to attend the clinic at the required time in the morning.

研究者

发起方

Almirall Prodesfarma S.A.

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