EUCTR2006-005848-87-DE进行中（未招募）不适用
A single-center, randomized, double-blind, vehicle-controlled study to assess the activity of CRx-191 in reducing the psoriatic infiltrate band thickness in plaque psoriasis.
适应症
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
- •- Subject must voluntarily give written informed consent
- •- Subject must be between 18 and 70 years of age
- •- Subject must have chronic plaque psoriasis and stable plaques in an area sufficient for six treatment fields
- •- The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study
- •- Sexually active females of childbearingpotential shoud either be surgically sterile (hysterectomy of tubal ligation), or should use a highly effective medically accepted contraceptive regimen. A highly effective method of birth control is defined as those which result in a lower failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
- •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
- •- Erythrodermic, guttate or pustular psoriasis
- •- Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
- •- Narrow angle glaucoma
- •- Hyperthyroidism by medical history, thyroid stimulating hormone (TSH) less than lower limit of normal (LLN), or receiving thyroid medication
- •- Intolerance to Lidocain
- •- Severe liver desease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values that exceed 2.5x upper limit of normal (ULN))
- •- Inflammatory dermatoses except psoriases, bacterial, viral and fungal skin infections (at the test plaques); facial rosacea
- •- Active varicella, tuberculosis, syphilis or post-vaccine reaction
- •- Autoimmune desease other than plaque psoriasis (e.g. lupus erythematosis and psoriatic arthritis)
- •- Known allergic reactions or hypersensitivity to any of the components of the study preparations
- •- Allergy to adhesives on the hydrocolloid dressing used in this study
- •- UV therapy in the four weeks before the study
- •- History of malignancy (except for treated or excised basal cell carcinoma)
- •- Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
- •- History of drug or alcohol abuse (as defined by the investigator)
- •- Symptoms of a clinically significant illness in the four weeks before the study that may influence the outcome of the study
- •- Positive for human immunodeficiency virus (HIV) antibody
- •- Positive for hepatitis C (HCV) antibody
- •- Positive for hepatitis B surface antigen (HBsAg)
- •- Subjects who require systemically acting medications for the treatment of psoriasis which might counter or influence the study objectives such as: Methotrexate, Cyclosporine, Anti-TNFa therapies
- •- Subjects who require medications that inhibit the CYP450 2D6 pathway such as: Quinidine, Cimetidine, Type 1 anti-arrhythmics, phenothiazines, selective serotonin reuptake inhibitors such as fluoxetine, paroxetine, and sertraline, reserpine, other anticholinergic drugs, and sympathomimetic drugs
- •- Topical treatments for psoriasis (except for salicylic acid in vaseline) in the four weeks preceding and during the study (topical corticosteroids disallowed for eigth weeks prior to the study on treated plaques)
- •- Systemic treatments in the two weeks preceding and during the study that may interact with any of the study drugs, such as: Glucocorticoids (po, im, iv), MAO inhibitors, Anti-depressants, Anti-seizure medications, anti-psychotics, antihistamines
- •- Treatments in the two weeks preceding and during the study that may aggravate psoriasis, such as: anti-malarials, beta-blockers
- •- Participation in another clinical trial and/or treatment received with any investigational agent within one month before the initial dose of study medication
- •- Female subject who is pregnant or lactating
- •- Significant UV exposure in the four weeks before the study
- •- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject´s return for follow-up visists on schedule
- •- other unspecified reasons that, in the opinion of the Investiagtor or sponsor make the subject unsuitable for enrollment
- •- Subject is institutionalized because of legal or regulatory order
研究者
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