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BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test

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ClinicalTrials.gov Identifier: NCT02940002
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BAY1003803 Drug: Clobetasol propionate Drug: Betamethasone/calcipotriene Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : October 12, 2016
Actual Primary Completion Date : January 27, 2017
Actual Study Completion Date : March 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: BAY1003803 0.1% lipophilic cream
BAY1003803 0.1% lipophilic cream (on plaque and healthy skin)
Drug: BAY1003803
Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect

Experimental: BAY1003803 0.1% ointment
BAY1003803 0.1% ointment (on plaque and healthy skin)
Drug: BAY1003803
Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect

Experimental: BAY1003803 0.01% lipophilic cream
BAY1003803 0.01% lipophilic cream (on plaque and healthy skin)
Drug: BAY1003803
Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect

Experimental: BAY1003803 0.01% ointment
BAY1003803 0.01% ointment (on plaque and healthy skin)
Drug: BAY1003803
Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect

Active Comparator: Clobetasol propionate
Clobetasol propionate ointment 0.05 % (on plaque and healthy skin)
Drug: Clobetasol propionate
Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect

Active Comparator: Betamethasone/calcipotriene
Betamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin)
Drug: Betamethasone/calcipotriene
Simultaneous application of 10μl on healthy skin for 4 weeks and evaluation of pharmacodynamic effect




Primary Outcome Measures :
  1. Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound [ Time Frame: Day 1 to 29 ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940002


Locations
Germany
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Bochum, Nordrhein-Westfalen, Germany, 44803
Hamburg, Germany, 20095
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02940002     History of Changes
Other Study ID Numbers: 17012
2016-000962-47 ( EudraCT Number )
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Keywords provided by Bayer:
Plaque form psoriasis vulgaris

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Clobetasol
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents