Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Zalicus
With
Bioskin GmbH
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen
You may not be if
Erythrodermic, guttate or pustular psoriasis
Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
Mania
Narrow angle glaucoma
Hyperthyroidism by medical history, thyroid stimulating hormone (TSH) less than lower limit of normal (LLN), or receiving thyroid medication
Intolerance to Lidocaine
Severe liver disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values that exceed 1.5x upper limit of normal (ULN))
Active varicella, tuberculosis, syphilis or post-vaccine reaction
Autoimmune disease 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 HIV antibody
Subjects who require systemically acting medications for the treatment of psoriasis which might counter or influence the study objectives such as: Methotrexate; Cyclosporine; Anti-TNFα therapies
Subjects who require medications that inhibit the CYP450 2D6 pathway such as: Quinidine; Cimetidine; Type 1 antiarrhythmics; 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 eight weeks prior to the study)
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 visits on schedule
Other unspecified reasons that, in the opinion of the Investigator or sponsor make the subject unsuitable for enrollment
Subject is institutionalized because of legal or regulatory order
