BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-12

Study Completion Date

2017-03-17

Brief Summary

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

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BAY1003803 0.1% lipophilic cream

BAY1003803 0.1% lipophilic cream (on plaque and healthy skin)

Group Type EXPERIMENTAL

BAY1003803

Intervention Type DRUG

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

BAY1003803 0.1% ointment

BAY1003803 0.1% ointment (on plaque and healthy skin)

Group Type EXPERIMENTAL

BAY1003803

Intervention Type DRUG

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

BAY1003803 0.01% lipophilic cream

BAY1003803 0.01% lipophilic cream (on plaque and healthy skin)

Group Type EXPERIMENTAL

BAY1003803

Intervention Type DRUG

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

BAY1003803 0.01% ointment

BAY1003803 0.01% ointment (on plaque and healthy skin)

Group Type EXPERIMENTAL

BAY1003803

Intervention Type DRUG

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

Clobetasol propionate

Clobetasol propionate ointment 0.05 % (on plaque and healthy skin)

Group Type ACTIVE_COMPARATOR

Clobetasol propionate

Intervention Type DRUG

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

Betamethasone/calcipotriene

Betamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin)

Group Type ACTIVE_COMPARATOR

Betamethasone/calcipotriene

Intervention Type DRUG

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

Interventions

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BAY1003803

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

Intervention Type DRUG

Clobetasol propionate

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

Intervention Type DRUG

Betamethasone/calcipotriene

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No