Status:
COMPLETED
A Single-Center Exploratory Study to Assess the Activity of CRx-197-002 in Plaque Psoriasis
Lead Sponsor:
Zalicus
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This will be a phase 2a single-center, randomized, blinded, vehicle-controlled exploratory study to assess the activity and safety of CRx-197 in subjects with plaque psoriasis. Approximately 20 male o...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00796211
Start Date
November 1 2008
End Date
January 1 2009
Last Update
January 15 2009
Active Locations (1)
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1
ProInnovera
Münster, Germany