BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: BAY1003803; Drug: Betamethasone/calcipotriene; Drug: Clobetasol propionate

• Registration Number: NCT02940002
• Lead Sponsor: Bayer

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-12
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-20
• Primary Completion: 2017-01-27
• Status Verified: 2017-03
• Study Completion: 2017-03-17
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAY1003803 0.1% lipophilic cream	BAY1003803	BAY1003803 0.1% lipophilic cream (on plaque and healthy skin)
BAY1003803 0.1% ointment	BAY1003803	BAY1003803 0.1% ointment (on plaque and healthy skin)
BAY1003803 0.01% lipophilic cream	BAY1003803	BAY1003803 0.01% lipophilic cream (on plaque and healthy skin)
BAY1003803 0.01% ointment	BAY1003803	BAY1003803 0.01% ointment (on plaque and healthy skin)
Betamethasone/calcipotriene	Betamethasone/calcipotriene	Betamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin)
Clobetasol propionate	Clobetasol propionate	Clobetasol propionate ointment 0.05 % (on plaque and healthy skin)

Primary Outcome Measures

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