healthy subjects
Conditions
Interventions
Product Name: Paroxetine hydrochloride ointment 0.1%
Pharmaceutical Form: Ointment
INN or Proposed INN: Paroxetine hydrochloride
Concentration unit: % percent
Concentration type: equal
Concentration n
Sponsors
Agis Industries (1983) ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • male or female subjects aged 18 to 64 years without disease other than psoriasis; • subjects with chronic stable plaque psoriasis (psoriasis vulgaris) and suitable target plaques of similar, moderate severity on the arms, trunk or legs which have been stable for at least one month prior to inclusion and have 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; • 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • subjects with guttate psoriasis, pustular psoriasis, psoriasis of the scalp and/or face only, or which was restricted to the elbows and/or knees; • subjects who require systemically acting medications for the treatment of psoriasis which might counter or influence the study objectives, e.g. corticosteroids, cytostatics; • local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks); • systemic treatment with antipsoriatics in the three months preceding and during the study; • treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic and anti-depressant drugs, anticoagulants, inhibitors of platelet aggregation and anti-thrombotics, immunotherapy, immuno supression agents, NSAIDs, anti-pruritics, retinoids, vitamin D analogues, vascular agents, anti-diabetic or anti-infective medications) or medications which are known to provoke or aggravate psoriasis, e.g. b-blocker, antimalarial drugs within two weeks before the beginning of the study and during the study; medications which do not influence the study aim for example for treatment of headache or cold may be used at the discretion of the investigator; • known allergic reactions to the active ingredients or other components of the study preparations, comparators or control; • evidence of drug abuse; • known positive HIV-test; • pregnancy or nursing; • UV-therapy within four weeks before beginning and during the study; • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; • participation in another clinical trial involving pharmaceutical products in the four weeks preceding and during the study; •in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is the assessment of the antipsoriatic efficacy of the study preparations in subjects with stable psoriatic plaques. Intraindividual comparison will be made with the vehicle, one commercial reference (calcipotriol) and a negative control. The psoriatic infiltrate will be measured by sonography, skin redness measured by chromametry and clinical skin condition evaluated by scoring. In addition photodocumentation will be performed. ;Secondary Objective: ;Primary end point(s): Primary endpoint for this study is the efficacy of the active study preparations compared to the corresponding vehicle using USE differences. Secondary endpoints are: · the USE-index · sonographic measurements of infiltrate thickness · chromametric measurements of redness (a*-values) · the AUC of the USE-index · clinical assessment scores for assessment of efficacy | — |
Countries
Germany
Outcome results
None listed