Determination of antipsoriatic efficacy of topical formulations and comparison to a brand medication and placebo in a psoriasis plaque test

INTERVENTION: Product Name: G&W formulation 1 Pharmaceutical Form: Ointment INN or Proposed INN: Calcipotriol Concentration unit: % percent Concentration type: equal Concentration number: 0.005‐ Pharmaceutical form of the placebo: Ointment Route of administration of the placebo: Topical use (Noncurrent) Product Name: G&W formulation 2 Pharmaceutical Form: Ointment INN or Proposed INN: Calcipotriol Concentration unit: % percent Concentration type: equal Concentration number: 0.005‐ Pharmaceutical form of the placebo: Ointment Route of administration of the placebo: Topical use (Noncurrent) Trade Name: Dovonex ointment Product Name: Dovonex Pharmaceutical Form: Ointment INN or Proposed INN: Calcipotriol Concentration unit: % percent Concentration type: equal Concentration number: 0.005‐ CONDITION: Male or female subjects aged 18 to 64 are eligible for the study insofar that they suffer from chronic plaque type psoriasis. PRIMARY OUTCOME: Main Objective: Demonstration of antipsoriatic efficacy of topical formulations in patients with psoriasis vulgaris Primary end point(s): Primary endpoint for this study is the efficacy of the active study preparations compared to the corresponding placebo using USE differences. Secondary Objective: INCLUSION CRITERIA: • male or female subjects aged 18 to 64 years; • subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with 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 use a medically accepted contraceptive regimen: surgically sterile (hysterectomy or tubal ligation), systemic contraceptive (oral, implant, injection), diaphragm with intravaginal spermicide, cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide; • written informed consent obtained. 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) no F.1.3.1 Number of subjects for