BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test

Psoriasis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940002
• Other study ID #: 17012
• Secondary ID: 2016-000962-47
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2016
• Last updated: March 20, 2017
• Start date: October 12, 2016
• Est. completion date: March 17, 2017

Study information

• Verified date: March 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 17, 2017
• Est. primary completion date: January 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound		Day 1 to 29

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