Randomised, placebo-controlled, double-blind, parallel-group, comparative study of two topical products for the treatment of psoriasis
- Conditions
- mild to moderate plaque psoriasis
- Registration Number
- EUCTR2009-012855-90-CZ
- Lead Sponsor
- Jelfa SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•clinical diagnosis of chronic, stable, mild to moderate plaque psoriasis affecting 5% to 20% of body surface area and PASI<12
•age 18 +
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
•erythrodermic psoriasis
•guttate psoriasis
•pustular psoriasis
•application of topical corticosteroids 2 weeks before enrollment to the study
•systemic biologic therapy
•spontaneous improvement during recent 2 months
•rapidly deteriorating psoriasis in recent 2 months
•uncontrolled systemic disease
•known hypersensitivity to any test products
•pregnancy and breasfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and safety of two combination products in patients with plaque psoriasis and to show therapeutic equivalence between test product and reference product. ;Secondary Objective: The efficacy of test and reference product will be also compared to placebo as a secondary endpoint.<br>Safety of the tested product.;Primary end point(s): •Psoriasis Area and Severity Index (PASI) score
- Secondary Outcome Measures
Name Time Method