EUCTR2009-016261-28-DE进行中（未招募）不适用
Randomized, observer-blind, multi-center, reference-controlled phase IIb study to evaluate the efficacy of topically applied LAS41002 lotion in the treatment of scalp psoriasis - Efficacy of LAS41002 lotion in the treatment of scalp psoriasis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Male or female patients 18-75 years of age
- •Chronic scalp psoriasis for at least 4 months before enrollment in this study
- •oTSS = 4 (at least one sign graded with 2, on each other sign a grade of 1 is required) up to 12
- •oExtent of scalp psoriasis involving more than 10 % of the total scalp area
- •All patients must give written informed consent before any assessment is performed.
- •General good health as determined by investigator based upon results of medical history
- •Scalp psoriasis is amenable for topical treamtent
- •Willingness to actively participate in the study and come to scheduled visits
- •Willingness to discontinue the use of their own topical psoriasis treatment at the scalp
- •Negative urine pregnancy test (in female patients of child bearing potential)
- •Reliable methods of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomized partner)
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who need systemic treatment for their body psoriasis
- •History of hypersensitivity to any of the study drugs or ingredients of the study drugs or to drugs of similar chemical classes
- •History of malignancy of any organ system
- •Atrophy of the scalp
- •Medication:
- •Systemic treatment that may interfere with the investigational product
- •Corticosteroids, antibiotics4 weeks prior to study day 1 and during conduct of study
- •Retinoids6 weeks prior to study day 1 and during conduct of study
- •Vitamin D supplements, hydroxycarbamide, azathioprine, meth-otrexate, cyclosporine4 weeks prior to study day 1 and during conduct of study
- •Immunomodulators3 months prior to study day 1 and during conduct of study
- •Treatment with biologicals with a possible effect on scalp psoriasis6 months prior to study day 1 and during conduct of study
- •Planned initiation of, or changes to concomitant medication that could affect psoriasis (e.g. beta blockers, anti-malaria drugs, lithium)
- •-Topical treatment of, scalp, face and neck (see table below):
- •Corticosteroids, antibiotics4 weeks prior to study day 1 and during conduct of study
- •Retinoids6 weeks prior to study day 1 and during conduct of study
- •Anti-inflammatory substances2 weeks prior to study day 1 and during conduct of study
- •Vitamin A analogues, Vitamin D analogues, Immunosuppressants, Anthracen derivates 2 weeks prior to study day 1 and during conduct of study
- •Salicylic acid preparations2 weeks prior to study day 1 and during conduct of study
- •Tar2 weeks prior to study day 1 and during conduct of study
- •UVB Therapy2 weeks prior to study day 1 and during conduct of study
- •PUVA Therapy4 weeks prior to study day 1 and during conduct of study
- •Neutral emollients1 week prior to study day 1 and during conduct of study
- •-Topical treatment with corticosteroids or immunosuppressants in case more than 20 % of the body surface area is treated
- •-Treatment with any non-marketed drug substance (i.e. an agent which had not yet been made available for clinical use following registration) within 4 weeks prior to study day 1
- •Planned use of chemical treatments of the hair (e.g. relaxers, perms or colorings) during the conduct of the study
- •Shampoos containing corticosteroids within 2 weeks before study day 1 and during the conduct of the study
- •Specific skin diseases (such as tuberculosis or syphilis)
- •Erythrodermic, exfoliative or pustular psoriasis
- •Skin infections caused by bacteria or viruses or fungal skin infection
- •Varicella zoster
- •Skin reactions after immunization
- •Rosaceae, perioral dermatitis
- •Moderate or severe illness within the last two weeks before first exposure
- •Known infectious diseases (e.g. hepatitis or AIDS)
- •Other inflammatory skin diseases that may confound the evaluation of psoriasis
- •Pregnancy or lactation
- •Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing
- •Any history of drug addiction or alcoholism in the past 3 years
- •Patients with poor compliance
- •Patients, who are inmates of psychiatric wards, prison or state institutions
- •Participation in a clinical trial within the last 30 days prior to the start of this study
- •Patients underlying any other restrictions due to the participation in other tests / test institutes
- •Employees of the study sites or of the Sponsor’s company
- •If in the opinion of the investigator the patient should not particip
研究者
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