Optimising Outpatient Care in Mild to Moderate Psoriasis (PSO-TOP)
A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board to overcome non-adherence problems.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Optimising Outpatient Care in Mild to Moderate Psoriasis by a Newly Developed 'Topical Treatment Optimising Programme' - an International Study Using Daivobet®/Dovobet® Gel|
- Physician Global Assessment (PGA) [ Time Frame: Up to 64 weeks; primary outcome assessed at week 8 after treatment start ] [ Designated as safety issue: No ]PGA (Physician Global Assessment) will be assessed at all study visits. For week 8, the rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 will be calculated. This is the primary study parameter.
|Study Start Date:||March 2012|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Topical Treatment Optimizing Program
Patient is taken care of in an intensified, optimised manner
non-Topical Treatment Optimizing Program
Standard medical care
A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board. This tool is created to address patients' non-adherence in topical therapy and the resulting underperformance of such treatments in controlling psoriatic disease. The study addresses the effect of the relationship between the patient and the health care professional, one of the important factors that can affect treatment adherence and therapeutic efficacy. The TTOP will be compared to standardised regular care (called 'non-TTOP'). It is intended to clinically show the importance of an optimised contact between the patient and health care professional.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587755
Show 94 Study Locations
|Principal Investigator:||Kristian Reich, MD Prof.|