NCT02940002

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

October 19, 2016

Last Update Submit

March 20, 2017

Conditions

Psoriasis

Keywords

Plaque form psoriasis vulgaris

Outcome Measures

Primary Outcomes (1)

  • Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound

    Day 1 to 29

Study Arms (6)

BAY1003803 0.1% lipophilic cream

EXPERIMENTAL

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

Drug: BAY1003803

BAY1003803 0.1% ointment

EXPERIMENTAL

BAY1003803 0.1% ointment (on plaque and healthy skin)

Drug: BAY1003803

BAY1003803 0.01% lipophilic cream

EXPERIMENTAL

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

Drug: BAY1003803

BAY1003803 0.01% ointment

EXPERIMENTAL

BAY1003803 0.01% ointment (on plaque and healthy skin)

Drug: BAY1003803

Clobetasol propionate

ACTIVE COMPARATOR

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

Drug: Clobetasol propionate

Betamethasone/calcipotriene

ACTIVE COMPARATOR

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

Drug: Betamethasone/calcipotriene

Interventions

BAY1003803DRUG

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

BAY1003803 0.01% lipophilic creamBAY1003803 0.01% ointmentBAY1003803 0.1% lipophilic creamBAY1003803 0.1% ointment
Clobetasol propionateDRUG

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

Clobetasol propionate
Betamethasone/calcipotrieneDRUG

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

Betamethasone/calcipotriene

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female (non-childbearing potential) volunteer with stable plaque-type psoriasis, but otherwise healthy
  • Age: 18-64 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Hamburg, Hamburg, 20095, Germany

Location

Unknown Facility

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

Unknown Facility

Bochum, North Rhine-Westphalia, 44803, Germany

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Clobetasolbetamethasone dipropionate, calcipotriol drug combination

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 20, 2016

Study Start

October 12, 2016

Primary Completion

January 27, 2017

Study Completion

March 17, 2017

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

DE(3)