BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test

Bayer

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: Betamethasone/calcipotriene; Drug: BAY1003803; Drug: Clobetasol propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02940002

17012

2016-000962-47 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 6 patient groups

BAY1003803 0.1% lipophilic cream

Experimental group

Description:

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

Treatment:

Drug: BAY1003803

BAY1003803 0.1% ointment

Experimental group

Description:

BAY1003803 0.1% ointment (on plaque and healthy skin)

Treatment:

Drug: BAY1003803

BAY1003803 0.01% lipophilic cream

Experimental group

Description:

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

Treatment:

Drug: BAY1003803

BAY1003803 0.01% ointment

Experimental group

Description:

BAY1003803 0.01% ointment (on plaque and healthy skin)

Treatment:

Drug: BAY1003803

Clobetasol propionate

Active Comparator group

Description:

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

Treatment:

Drug: Clobetasol propionate

Betamethasone/calcipotriene

Active Comparator group

Description:

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

Treatment:

Drug: Betamethasone/calcipotriene