BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test

• Status: Completed
• Trial end date: 2017-03-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Calcipotriene; Calcitriol; Clobetasol

Criteria

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