A Single-Center Exploratory Study to Assess the Activity of CRx-197-002 in Plaque Psoriasis

Inclusion criteria

• I01 Subject must voluntarily sign and date the written informed consent prior to any study specific procedures
• I02 Subject must be 18 to 70 years of age
• I03 Subject must have chronic plaque psoriasis and plaque infiltrates of a thickness of a minimum of 150 µm and stable plaques in an area sufficient for up to five test fields and an untreated control field per each plaque
• I04 Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
• I05 Females of childbearing potential age should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen.

Exclusion criteria

• E01 Erythrodermic, guttate or pustular psoriasis
• E02 Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias or valvular heart disease
• E03 Mania or acute delirium or epilepsy
• E04 Narrow angle glaucoma
• E05 Hyperthyroidism by medical history, TSH less than LLN, or a subject receiving thyroid medication
• E06 Diabetes
• E07 Intolerance to lidocaine
• E08 Severe liver disease [ALT laboratory value that exceeds 2.5x ULN]
• E09 Known severe kidney disease, acute urinary retention, prostatic hypertrophy with post void residual urine or laboratory value of creatinine that exceeds 1.5x ULN
• E10 Significant gastrointestinal disease including but not limited to pyloric stenosis or paralytic ileus
• E11 Inflammatory dermatoses except psoriasis; bacterial, viral, or fungal skin infections (at the test plaques); facial rosacea
• E12 Active varicella, tuberculosis, syphilis or post-vaccine reactions
• E13 Autoimmune disease other than plaque psoriasis (e.g., lupus erythematosis)
• E14 Known allergic reactions or hypersensitivity to any of the components of the study treatments
• E15 Allergy to adhesives on the templates used in this study
• E16 UV therapy or significant UV exposure in the four weeks before treatment application
• E17 History of malignancy (except for treated or excised basal cell carcinoma)
• E18 History of drug or alcohol abuse (as defined by the Investigator)
• E19 Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study
• E20 Subject with demonstrated hypercalcemia (calcium greater than ULN) or evidence of Vitamin D toxicity
• E21 Subject with demonstrated hypokalemia (less than LLN)