Antipsoriatic Effect of a Topical Formulation for the Treatment of Psoriasis Vulgaris
The current most important topical treatments for psoriasis are vitamin D3 analogues and/or corticosteroids. The possibility of another effective treatment for psoriasis could be based on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel.
The aim of the clinical trial is to evaluate the safety, tolerability and anti-psoriatic efficacy of topical SPS4251 formulations in comparison to placebo and to a marketed topical Vitamin-D analogue ointment in a psoriasis plaque test.
|Psoriasis Vulgaris||Drug: SPS4251 Ointment Drug: Placebo Drug: Daivonex® ointment||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase Ib, Two-centre, Randomised, Observer-blind, Placebo- and Comparator Controlled Trial to Evaluate the Safety, Tolerability and Antipsoriatic Efficacy of Three Strengths of a Topical SPS4251 Formulation in a Psoriasis Plaque Test|
- Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate [ Time Frame: Up to Day 12 ]
- Evaluation of anti-psoriatic efficacy by clinical assessment [ Time Frame: Up to day 12 ]
- Number of subjects with Adverse Events [ Time Frame: Up to day 12 ]
|Study Start Date:||March 2013|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Psoriasis Plaque Test
SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment
Drug: SPS4251 Ointment
Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments)Drug: Placebo
Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments)Drug: Daivonex® ointment
Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments).
Other Name: calcipotriol
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743118