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Completed

NCT Number: NCT02940002

BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hamburg, Free and Hanseatic City of Hamburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY1003803

Drug

Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect

Clobetasol propionate

Drug

Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect

Betamethasone/calcipotriene

Drug

Simultaneous application of 10μl on healthy skin for 4 weeks and evaluation of pharmacodynamic effect

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2016
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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