Psoriasis Investigation of 4 different treatment regimes

Conditions: Psoriasis vulgaris
MedDRA version: 8.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

Registration Number: EUCTR2006-006026-25-DK

Lead Sponsor: Coloplast A/S, Consumer Products

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures