Study Completed

Psoriasis

Bayer Identifier:

17012

ClinicalTrials.gov Identifier:

NCT02940002

EudraCT Number:

2016-000962-47

EU CT Number:

Not Available

BAY1003803 formulation comparison in open Psoriasis Plaque Test

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 64 Years

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

Trial summary

Enrollment Goal

Trial Dates

October 2016 - March 2017

Phase

Phase 1

Could I Receive a placebo

Products

BAY1003803

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Hamburg, 20095, Germany
Completed		Schwerin, 19055, Germany
Completed		Bochum, 44803, Germany

Primary Outcome

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
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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