check_circleStudy 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
  • - Male and female (non-childbearing potential) volunteer with stable plaque-type psoriasis, but otherwise healthy
    - Age: 18-64 years


  • - 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
23
Trial Dates
October 2016 - March 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1003803
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    Day 1 to 29
    enhanced_encryption
    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
6

Additional Information

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