mild to moderate plaque psoriasis
Conditions
Interventions
Trade Name: DIPROSALIC
Product Name: Diprosalic
Pharmaceutical Form: Ointment
INN or Proposed INN: betamethasoni dipropionas
Concentration unit: mg/g milligram(s)/gram
Concentration number: 0,5-
INN o
Sponsors
Jelfa SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • clinical diagnosis of chronic, stable, mild to moderate plaque psoriasis affecting 5% to 20% of body surface area and PASI=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Safety of the tested product.;Primary end point(s): • Psoriasis Area and Severity Index (PASI) score | — |
Countries
Czech Republic
Outcome results
None listed