PsoriasisPhase 1NCT02940002
BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test
A Phase 1 study testing BAY1003803, Clobetasol propionate and Betamethasone/calcipotriene in people with Psoriasis, run by Bayer at 3 sites in Germany.
Trial summary
To explore the efficacy and safety of four BAY1003803 formulations by means of a within subject comparison in an open Psoriasis Plaque Test Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- BAY1003803, Clobetasol propionate and Betamethasone/calcipotriene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesGermany
- Study dates
- 12 Oct 2016to 17 Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female (non-childbearing potential) volunteer with stable plaque-type psoriasis, but otherwise healthy
- Age: 18-64 years
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Germany3 sites
Study site
Bochum, North Rhine-Westphalia, 44803
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20095
Study site
Schwerin, Mecklenburg-Vorpommern, 19055
About this study
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
To explore the efficacy and safety of four BAY1003803 formulations by means of a within subject comparison in an open Psoriasis Plaque Test
- Conditions
- Psoriasis
- Being tested
- BAY1003803, Clobetasol propionate, Betamethasone/calcipotriene
- Keywords
- Plaque form psoriasis vulgaris
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1003803Drug
Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
Clobetasol propionateDrug
Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
Betamethasone/calcipotrieneDrug
Simultaneous application of 10μl on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
| Study group | Role | What they receive |
|---|---|---|
| BAY1003803 0.1% lipophilic cream | Experimental | BAY1003803 0.1% lipophilic cream (on plaque and healthy skin) Receives: Drug: BAY1003803 |
| BAY1003803 0.1% ointment | Experimental | BAY1003803 0.1% ointment (on plaque and healthy skin) Receives: Drug: BAY1003803 |
| BAY1003803 0.01% lipophilic cream | Experimental | BAY1003803 0.01% lipophilic cream (on plaque and healthy skin) Receives: Drug: BAY1003803 |
| BAY1003803 0.01% ointment | Experimental | BAY1003803 0.01% ointment (on plaque and healthy skin) Receives: Drug: BAY1003803 |
| Clobetasol propionate | Active comparator | Clobetasol propionate ointment 0.05 % (on plaque and healthy skin) Receives: Drug: Clobetasol propionate |
| Betamethasone/calcipotriene | Active comparator | Betamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin) Receives: Drug: Betamethasone/calcipotriene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound
Measured: Day 1 to 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start12 Oct 2016
- Primary completion27 Jan 2017
- Study completion17 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940002
- Sponsor's protocol ID
- 17012
- Other IDs
- 2016-000962-47, 2016
- Status last verified
- Mar 2017
- First submitted
- 19 Oct 2016
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02940002
- Acronym / sponsor ID
- 17012
- Conditions
- Psoriasis
- Keywords
- Plaque form psoriasis vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the efficacy and safety of four BAY1003803 formulations by means of a within subject comparison in an open Psoriasis Plaque Test
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BAY1003803 0.1% lipophilic cream | Experimental | Drug: BAY1003803BAY1003803 0.1% lipophilic cream (on plaque and healthy skin) |
| BAY1003803 0.1% ointment | Experimental | Drug: BAY1003803BAY1003803 0.1% ointment (on plaque and healthy skin) |
| BAY1003803 0.01% lipophilic cream | Experimental | Drug: BAY1003803BAY1003803 0.01% lipophilic cream (on plaque and healthy skin) |
| BAY1003803 0.01% ointment | Experimental | Drug: BAY1003803BAY1003803 0.01% ointment (on plaque and healthy skin) |
| Clobetasol propionate | Active comparator | Drug: Clobetasol propionateClobetasol propionate ointment 0.05 % (on plaque and healthy skin) |
| Betamethasone/calcipotriene | Active comparator | Drug: Betamethasone/calcipotrieneBetamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and female (non-childbearing potential) volunteer with stable plaque-type psoriasis, but otherwise healthy
- Age: 18-64 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY1003803Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect | Drug | BAY1003803 0.01% lipophilic cream, BAY1003803 0.01% ointment, BAY1003803 0.1% lipophilic cream, BAY1003803 0.1% ointment |
| Clobetasol propionateSimultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect | Drug | Clobetasol propionate |
| Betamethasone/calcipotrieneSimultaneous application of 10μl on healthy skin for 4 weeks and evaluation of pharmacodynamic effect | Drug | Betamethasone/calcipotriene |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
Related trials for Psoriasis
RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Plaque Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY1003803, Clobetasol propionate and Betamethasone/calcipotriene in people with Psoriasis, run by Bayer at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.