Trial Condition(s):
Psoriasis
BAY1003803 formulation comparison in open Psoriasis Plaque Test
Bayer Identifier:
17012
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Inclusion Criteria
- Male and female (non-childbearing potential) volunteer with stable plaque-type psoriasis, but otherwise healthy
- Age: 18-64 yearsExclusion 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 deviationTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Hamburg, Germany, 20095 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Schwerin, Germany, 19055 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bochum, Germany, 44803 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasoundTimeframe: Day 1 to 29
Additional Information
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