Back to resultsBAY1003803 Formulation Comparison in Open Psoriasis Plaque Test
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BAY1003803
Clobetasol propionate
Betamethasone/calcipotriene
Sponsored by
About this trial
This is an interventional other trial for Psoriasis focused on measuring Plaque form psoriasis vulgaris
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
BAY1003803 0.1% lipophilic cream
BAY1003803 0.1% ointment
BAY1003803 0.01% lipophilic cream
BAY1003803 0.01% ointment
Clobetasol propionate
Betamethasone/calcipotriene
Arm Description
BAY1003803 0.1% lipophilic cream (on plaque and healthy skin)
BAY1003803 0.1% ointment (on plaque and healthy skin)
BAY1003803 0.01% lipophilic cream (on plaque and healthy skin)
BAY1003803 0.01% ointment (on plaque and healthy skin)
Clobetasol propionate ointment 0.05 % (on plaque and healthy skin)
Betamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin)
Outcomes
Primary Outcome Measures
Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02940002
Brief Title
BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 12, 2016 (Actual)
Primary Completion Date
January 27, 2017 (Actual)
Study Completion Date
March 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Plaque form psoriasis vulgaris
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BAY1003803 0.1% lipophilic cream
Arm Type
Experimental
Arm Description
BAY1003803 0.1% lipophilic cream (on plaque and healthy skin)
Arm Title
BAY1003803 0.1% ointment
Arm Type
Experimental
Arm Description
BAY1003803 0.1% ointment (on plaque and healthy skin)
Arm Title
BAY1003803 0.01% lipophilic cream
Arm Type
Experimental
Arm Description
BAY1003803 0.01% lipophilic cream (on plaque and healthy skin)
Arm Title
BAY1003803 0.01% ointment
Arm Type
Experimental
Arm Description
BAY1003803 0.01% ointment (on plaque and healthy skin)
Arm Title
Clobetasol propionate
Arm Type
Active Comparator
Arm Description
Clobetasol propionate ointment 0.05 % (on plaque and healthy skin)
Arm Title
Betamethasone/calcipotriene
Arm Type
Active Comparator
Arm Description
Betamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin)
Intervention Type
Drug
Intervention Name(s)
BAY1003803
Intervention Description
Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
Intervention Type
Drug
Intervention Name(s)
Clobetasol propionate
Intervention Description
Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
Intervention Type
Drug
Intervention Name(s)
Betamethasone/calcipotriene
Intervention Description
Simultaneous application of 10μl on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19055
Country
Germany
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44803
Country
Germany
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test
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