BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: BAY1003803; Drug: Clobetasol propionate; Drug: Betamethasone/calcipotriene

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20095
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44803

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BAY1003803 0.1% lipophilic cream; BAY1003803 0.1% lipophilic cream (on plaque and healthy skin)	Drug: BAY1003803; Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
EXPERIMENTAL: BAY1003803 0.1% ointment; BAY1003803 0.1% ointment (on plaque and healthy skin)	Drug: BAY1003803; Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
EXPERIMENTAL: BAY1003803 0.01% lipophilic cream; BAY1003803 0.01% lipophilic cream (on plaque and healthy skin)	Drug: BAY1003803; Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
EXPERIMENTAL: BAY1003803 0.01% ointment; BAY1003803 0.01% ointment (on plaque and healthy skin)	Drug: BAY1003803; Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
ACTIVE_COMPARATOR: Clobetasol propionate; Clobetasol propionate ointment 0.05 % (on plaque and healthy skin)	Drug: Clobetasol propionate; Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
ACTIVE_COMPARATOR: Betamethasone/calcipotriene; Betamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin)	Drug: Betamethasone/calcipotriene; Simultaneous application of 10μl on healthy skin for 4 weeks and evaluation of pharmacodynamic effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 12, 2016
• Primary Completion (ACTUAL): January 27, 2017
• Study Completion (ACTUAL): March 17, 2017

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (ESTIMATE): October 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Plaque form psoriasis vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Calcipotriene; Clobetasol
• Other Study ID Numbers: 17012; 2016-000962-47 (EUDRACT_NUMBER)