BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test

Study Overview
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Brief Summary
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To explore the efficacy and safety of four BAY1003803 formulations by means of a within subject comparison in an open Psoriasis Plaque Test

Official Title
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A 28-day, Double-blind, Randomized, Reference-controlled Psoriasis Plaque Test to Evaluate the Efficacy and Safety of Two Different BAY1003803 Formulation Types in 2 Concentrations Each in Treatment of Symptomatic Volunteers With Plaque-type Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: BAY1003803
* Drug: Clobetasol propionate
* Drug: Betamethasone/calcipotriene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female (non-childbearing potential) volunteer with stable plaque-type psoriasis, but otherwise healthy Age: 18-64 years Exclusion Criteria: Severe disease within the last 4 weeks prior to the first study drug administration as determined by the investigator Any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar, except for salicylic acid (Pretreatment) in the 4 weeks before first treatment and/or planned during the trial, except for allowed topical treatment on the face, ears and scalp Systemic treatment depending on kind of treatment within 4 weeks and 6 months prior and/or planned during the trial Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, lithium, beta-blockers or angiotensin-converting-enzyme inhibitors (AEC inhibitors) unless on a stable dose for 3 months before study medication initiation Clinico-chemical parameters of clinically significant deviation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY1003803 0.1% lipophilic cream<br>BAY1003803 0.1% lipophilic cream (on plaque and healthy skin) | Drug: BAY1003803<br>* Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect<br>|
| Experimental: BAY1003803 0.1% ointment<br>BAY1003803 0.1% ointment (on plaque and healthy skin) | Drug: BAY1003803<br>* Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect<br>|
| Experimental: BAY1003803 0.01% lipophilic cream<br>BAY1003803 0.01% lipophilic cream (on plaque and healthy skin) | Drug: BAY1003803<br>* Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect<br>|
| Experimental: BAY1003803 0.01% ointment<br>BAY1003803 0.01% ointment (on plaque and healthy skin) | Drug: BAY1003803<br>* Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect<br>|
| Active Comparator: Clobetasol propionate<br>Clobetasol propionate ointment 0.05 % (on plaque and healthy skin) | Drug: Clobetasol propionate<br>* Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect<br>|
| Active Comparator: Betamethasone/calcipotriene<br>Betamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin) | Drug: Betamethasone/calcipotriene<br>* Simultaneous application of 10μl on healthy skin for 4 weeks and evaluation of pharmacodynamic effect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound |  | Day 1 to 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque form psoriasis vulgaris