PsoriasisPhase 1NCT03399526
1404003_OpenPsori.PlaqueTest to Eval.Eff.of Diff.Comp. to Mapracorat
A Phase 1 study testing Mapracorat (ZK 245186, BAY 86-5319), Prednicarbate 0.25% ointment and Clobetasol 0.05% ointment in people with Psoriasis, run by Bayer at 1 site in Germany.
Trial summary
Evaluation of efficacy and safety of Mapracorat 0.1% ointment and 4 comparator ointments in male and female subjects 18 to 65 years with stable plaque-type psoriasis treated once daily 6 days a week for a maximum of 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Mapracorat (ZK 245186, BAY 86-5319), Prednicarbate 0.25% ointment and Clobetasol 0.05% ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 11 Feb 2013to 31 May 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 to 65 years of age with stable plaque-type psoriasis, plaques of adequate size to allow for evaluation of 5 test fields, on comparable body area; thickness of the echo-lucent band under the entry echo as assessed by ultrasound of at least 200 μm
Who cannot join
- Positive testing in urine drug screening
- Pregnancy or lactation
- A history of relevant diseases, especially-incompletely cured pre-existing diseases for which it could have been assumed that the absorption, distribution, excretion and effect of the study drugs would not be normal
- Volunteers with severe kidney or liver disease
- Volunteers with concurrent/acute viral infections in the test field areas (e.g. herpes simplex, varicella) or other specific skin alterations (skin tuberculosis, syphilitic skin lesions)
- Severe disease within the last 4 weeks prior to the first study drug administration
Show all 18Show fewer
- Volunteers with known hypersensitivity reaction when applying adhesive bandages
- Volunteers who were treated with any systemic therapy for psoriasis (e.g. methotrexate, cyclosporin A, etretinate, acitretin, PUVA, fumaric acid) three months prior to screening
- Volunteers who were treated with any systemic corticosteroids (oral, intramuscular, high-dose inhaled, rectal) 4 weeks prior to screening
- Volunteers who were treated with any local therapy for psoriasis (e.g. corticosteroids, calcitriol analogues, dithranol, phototherapy) 2 weeks prior to screening
- Target plaques localized on head and neck, elbows and knees, palms and soles, nails and folds or other mechanically strained sites
- Volunteers with guttate or pustular psoriasis
- Volunteers with spontaneously improving or rapidly deteriorating plaque-type psoriasis
- Volunteers with erythrodermic type of psoriasis
- Volunteers with severe recalcitrant psoriasis requiring additional therapy
- Presence of hepatitis B virus surface antigen, hepatitis C virus antibodies or human immune deficiency virus antibodies
- Clinico-chemical parameters of clinically significant deviation
- Volunteers with a known allergy to any of the excipients of the trial medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 28-day, Double-blind, Randomized, Reference-controlled Open Psoriasis Plaque Test for Within Subject Comparison of Efficacy and Safety of Mapracorat 0.1% Ointment and 4 Reference Products in Symptomatic Volunteers With Stable Plaque-type Psoriasis
Evaluation of efficacy and safety of Mapracorat 0.1% ointment and 4 comparator ointments in male and female subjects 18 to 65 years with stable plaque-type psoriasis treated once daily 6 days a week for a maximum of 4 weeks.
Primary objective was to compare the efficacy of all test compounds by measurement of psoriatic infiltrate thickness (PIT) with 20 MHz B mode ultrasound.
Secondary objectives were to assess safety of all test compounds by measurement of the atrophogenic potential on non-lesional skin with 20 MHz B mode ultrasound, to assess the efficacy of all test compounds by measurement of intensity of erythema measured by chromametry, to assess the efficacy of all test compounds by visual assessment of the skin in the test fields using a 5-point score, to assess the safety of all test compounds by visual assessments of formation of teleangiectasia using a 5-point score, to assess the safety of all test compounds by visual assessment of atrophy using a 5-point score, to assess the safety of all test compounds by visual assessment of local tolerability using a 5-point score, to visualize the therapeutic index given by PIT versus non lesional skin thickness.
- Conditions
- Psoriasis
- Being tested
- Mapracorat (ZK 245186, BAY 86-5319), Prednicarbate 0.25% ointment, Clobetasol 0.05% ointment, Calcipotriene 0.005% ointment, Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mapracorat (ZK 245186, BAY 86-5319)Drug
0.1% (1 mg/g) of the active ingredient mapracorat plus excipients as ointment
Prednicarbate 0.25% ointmentDrug
0.25% (2.5 mg/g) of the active ingredient prednicarbate as ointment
Clobetasol 0.05% ointmentDrug
0.05% (0.5 mg/g) of the active ingredient clobetasol as ointment
Calcipotriene 0.005% ointmentDrug
0.005% (0.05 mg/g) of the active ingredient calcipotriene as ointment
Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointmentDrug
0.005% (0.05 mg/g) of the active ingredient calcipotriene/0.05% (0.5 mg/g) of the active ingredient betamethasone dipropionate as ointment
| Study group | Role | What they receive |
|---|---|---|
| Mapracorat | Experimental | 10 µL of mapracorat was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of mapracorat was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 Receives: Drug: Mapracorat (ZK 245186, BAY 86-5319) |
| Prednicarbate | Active comparator | 10 µL of prednicarbate was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of prednicarbate was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 Receives: Drug: Prednicarbate 0.25% ointment |
| Clobetasol | Active comparator | 10 µL of clobetasol was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of clobetasol was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 Receives: Drug: Clobetasol 0.05% ointment |
| Calcipotriene | Active comparator | 10 µL of calcipotriene was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of calcipotriene was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 Receives: Drug: Calcipotriene 0.005% ointment |
| Calcipotriene/Betamethasone dipropionate | Active comparator | 10 µL of calcipotriene/betamethasone dipropionate was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of calcipotriene/betamethasone dipropionate was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 Receives: Drug: Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-corrected area under the curve of the psoriatic infiltrate thickness (PIT) measured by 20 MHz B mode ultrasound
Assessment was done on the test fields on psoriatic plaques
Measured: Prior to drug application from Day 1 and up to Day 29
Secondary outcomes (8)
Skin thickness measurement of occluded test field on non-lesional skin (mean of triplicate measurement)
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Measured: Prior to drug application from Day 1 up to Day 60
Clinical assessment of atrophy using a 5-point score
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Measured: Prior to drug application from Day 1 and up to Day 29
Clinical assessment of telangiectasia using a 5-point score
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Measured: Prior to drug application from Day 1 and up to Day 29
Clinical assessment of local tolerability using a 5-point score
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Measured: Prior to drug application from Day 1 and up to Day 29
PIT measured by 20 MHz B mode ultrasound
Assessment was done on the test fields on psoriatic plaques
Measured: Prior to drug application from Day 1 and up to Day 29
Measurement of erythema using chromametry (mean of triplicate measurement)
Assessment was done on the test fields on psoriatic plaques
Measured: Prior to drug application from Day 1 and up to Day 29
Clinical efficacy assessment of the skin in the test fields using a 5-point score
Assessment was done on the test fields on psoriatic plaques
Measured: Prior to drug application from Day 1 and up to Day 29
Number of participants with adverse events
Measured: Approximately 64-84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start11 Feb 2013
- Primary completion31 May 2013
- Study completion31 May 2013
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT03399526
- Sponsor's protocol ID
- 16599
- Other IDs
- 2012-004171-39
- Status last verified
- Dec 2017
- First submitted
- 9 Jan 2018
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 28-day, Double-blind, Randomized, Reference-controlled Open Psoriasis Plaque Test for Within Subject Comparison of Efficacy and Safety of Mapracorat 0.1% Ointment and 4 Reference Products in Symptomatic Volunteers With Stable Plaque-type Psoriasis
- ClinicalTrials.gov ID
- NCT03399526
- Acronym / sponsor ID
- 16599
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2013 (actual)
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 31 May 2013 (actual)
- First posted
- 16 Jan 2018 (actual)
- 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.
Evaluation of efficacy and safety of Mapracorat 0.1% ointment and 4 comparator ointments in male and female subjects 18 to 65 years with stable plaque-type psoriasis treated once daily 6 days a week for a maximum of 4 weeks.
Primary objective was to compare the efficacy of all test compounds by measurement of psoriatic infiltrate thickness (PIT) with 20 MHz B mode ultrasound.
Secondary objectives were to assess safety of all test compounds by measurement of the atrophogenic potential on non-lesional skin with 20 MHz B mode ultrasound, to assess the efficacy of all test compounds by measurement of intensity of erythema measured by chromametry, to assess the efficacy of all test compounds by visual assessment of the skin in the test fields using a 5-point score, to assess the safety of all test compounds by visual assessments of formation of teleangiectasia using a 5-point score, to assess the safety of all test compounds by visual assessment of atrophy using a 5-point score, to assess the safety of all test compounds by visual assessment of local tolerability using a 5-point score, to visualize the therapeutic index given by PIT versus non lesional skin thickness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Mapracorat | Experimental | Drug: Mapracorat (ZK 245186, BAY 86-5319)10 µL of mapracorat was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of mapracorat was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 |
| Prednicarbate | Active comparator | Drug: Prednicarbate 0.25% ointment10 µL of prednicarbate was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of prednicarbate was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 |
| Clobetasol | Active comparator | Drug: Clobetasol 0.05% ointment10 µL of clobetasol was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of clobetasol was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 |
| Calcipotriene | Active comparator | Drug: Calcipotriene 0.005% ointment10 µL of calcipotriene was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of calcipotriene was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 |
| Calcipotriene/Betamethasone dipropionate | Active comparator | Drug: Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment10 µL of calcipotriene/betamethasone dipropionate was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of calcipotriene/betamethasone dipropionate was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female subjects 18 to 65 years of age with stable plaque-type psoriasis, plaques of adequate size to allow for evaluation of 5 test fields, on comparable body area; thickness of the echo-lucent band under the entry echo as assessed by ultrasound of at least 200 μm
Key exclusion criteria (18 listed)
- Positive testing in urine drug screening
- Pregnancy or lactation
- A history of relevant diseases, especially-incompletely cured pre-existing diseases for which it could have been assumed that the absorption, distribution, excretion and effect of the study drugs would not be normal
- Volunteers with severe kidney or liver disease
- Volunteers with concurrent/acute viral infections in the test field areas (e.g. herpes simplex, varicella) or other specific skin alterations (skin tuberculosis, syphilitic skin lesions)
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 |
|---|---|---|
| Mapracorat (ZK 245186, BAY 86-5319)0.1% (1 mg/g) of the active ingredient mapracorat plus excipients as ointment | Drug | Mapracorat |
| Prednicarbate 0.25% ointment0.25% (2.5 mg/g) of the active ingredient prednicarbate as ointment | Drug | Prednicarbate |
| Clobetasol 0.05% ointment0.05% (0.5 mg/g) of the active ingredient clobetasol as ointment | Drug | Clobetasol |
| Calcipotriene 0.005% ointment0.005% (0.05 mg/g) of the active ingredient calcipotriene as ointment | Drug | Calcipotriene |
| Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment0.005% (0.05 mg/g) of the active ingredient calcipotriene/0.05% (0.5 mg/g) of the active ingredient betamethasone dipropionate as ointment | Drug | Calcipotriene/Betamethasone dipropionate |
Primary outcome
Baseline-corrected area under the curve of the psoriatic infiltrate thickness (PIT) measured by 20 MHz B mode ultrasound
Time frame: Prior to drug application from Day 1 and up to Day 29
Assessment was done on the test fields on psoriatic plaques
8 secondary outcomes
Skin thickness measurement of occluded test field on non-lesional skin (mean of triplicate measurement)
Time frame: Prior to drug application from Day 1 up to Day 60
Clinical assessment of atrophy using a 5-point score
Time frame: Prior to drug application from Day 1 and up to Day 29
Clinical assessment of telangiectasia using a 5-point score
Time frame: Prior to drug application from Day 1 and up to Day 29
Clinical assessment of local tolerability using a 5-point score
Time frame: Prior to drug application from Day 1 and up to Day 29
PIT measured by 20 MHz B mode ultrasound
Time frame: Prior to drug application from Day 1 and up to Day 29
Measurement of erythema using chromametry (mean of triplicate measurement)
Time frame: Prior to drug application from Day 1 and up to Day 29
Clinical efficacy assessment of the skin in the test fields using a 5-point score
Time frame: Prior to drug application from Day 1 and up to Day 29
Number of participants with adverse events
Time frame: Approximately 64-84 days
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 16 Jan 2018.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mapracorat (ZK 245186, BAY 86-5319), Prednicarbate 0.25% ointment and Clobetasol 0.05% ointment in people with Psoriasis, run by Bayer at 1 site 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 1 inclusion and 18 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 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Baseline-corrected area under the curve of the psoriatic infiltrate thickness (PIT) measured by 20 MHz B mode ultrasound (time frame: Prior to drug application from Day 1 and up to Day 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 16 Jan 2018.