BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02940002

Enrollment

Registered

2016-10-20

Start date

2016-10-12

Completion date

2017-03-17

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Plaque form psoriasis vulgaris

Brief summary

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

Interventions

DRUGBAY1003803

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

DRUGClobetasol propionate

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

DRUGBetamethasone/calcipotriene

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026