Psoriasis vulgaris MedDRA version: 8.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Trade Name: Diproderm cream 0,05%
Pharmaceutical Form: Cream
Sponsors
Coloplast A/S, Consumer Products
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female age 18-65 years. • Generally physically mobile. • Willingness to sign an Informed Consent Form • Understand spoken as well as written Danish • Suffering from psoriasis vulgaris with a minimum of 4 plaques size 2-4 cm. in diameter located at arms, legs or body • Willingness to stop any systemic treatment of this condition during the test period – and 30 days prior to test start up • Willingness to pause any other treatment of the 4 plaques selected for the study 14 days prior to the test period - both creams and other treatments. 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 this age range
Exclusion criteria
Exclusion criteria: • Must not suffer from any skin diseases that investigator finds will have influence on the outcome of the study – eigther with respect to the placement of the skin disease or the treatment of the skin disease • Must not suffer from diabetes mellitus • Must not be in systemic steroid treatment or have been so during the last 30 days prior to study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): Size of plaques and PASI score;Main Objective: This study is an explorative study on 3 newly developed treatments or treatment regimes. The aim is to get an indication of performance of the treatments or treatment regimes – and how the new regimes perform compared to daily treatment with a steroid cream (control). Performance is understood to include reduction of size of plaques, reduction of PASI scores, safety, treatment preference and absence of major negatives. | — |
Countries
Denmark
Outcome results
None listed