BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 27, 2017

Interventions

  • Drug: BAY1003803
    • Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
  • Drug: Clobetasol propionate
    • Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
  • Drug: Betamethasone/calcipotriene
    • Simultaneous application of 10μl on healthy skin for 4 weeks and evaluation of pharmacodynamic effect

Arms, Groups and Cohorts

  • Experimental: BAY1003803 0.1% lipophilic cream
    • BAY1003803 0.1% lipophilic cream (on plaque and healthy skin)
  • Experimental: BAY1003803 0.1% ointment
    • BAY1003803 0.1% ointment (on plaque and healthy skin)
  • Experimental: BAY1003803 0.01% lipophilic cream
    • BAY1003803 0.01% lipophilic cream (on plaque and healthy skin)
  • Experimental: BAY1003803 0.01% ointment
    • BAY1003803 0.01% ointment (on plaque and healthy skin)
  • Active Comparator: Clobetasol propionate
    • Clobetasol propionate ointment 0.05 % (on plaque and healthy skin)
  • Active Comparator: Betamethasone/calcipotriene
    • Betamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin)

Clinical Trial Outcome Measures

Primary Measures

  • Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound
    • Time Frame: Day 1 to 29

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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