Back to results1404003_OpenPsori.PlaqueTest to Eval.Eff.of Diff.Comp. to Mapracorat
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Mapracorat
Prednicarbate
Clobetasol
Calcipotriene
Calcipotriene/Betamethasone dipropionate
Arm Description
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
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
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
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Clinical assessment of atrophy using a 5-point score
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Clinical assessment of telangiectasia using a 5-point score
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
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
PIT measured by 20 MHz B mode ultrasound
Assessment was done on the test fields on psoriatic plaques
Measurement of erythema using chromametry (mean of triplicate measurement)
Assessment was done on the test fields on psoriatic plaques
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
Number of participants with adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03399526
Brief Title
1404003_OpenPsori.PlaqueTest to Eval.Eff.of Diff.Comp. to Mapracorat
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 11, 2013 (Actual)
Primary Completion Date
May 31, 2013 (Actual)
Study Completion Date
May 31, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mapracorat
Arm Type
Experimental
Arm Description
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
Arm Title
Prednicarbate
Arm Type
Active Comparator
Arm Description
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
Arm Title
Clobetasol
Arm Type
Active Comparator
Arm Description
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
Arm Title
Calcipotriene
Arm Type
Active Comparator
Arm Description
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
Arm Title
Calcipotriene/Betamethasone dipropionate
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Mapracorat (ZK 245186, BAY 86-5319)
Intervention Description
0.1% (1 mg/g) of the active ingredient mapracorat plus excipients as ointment
Intervention Type
Drug
Intervention Name(s)
Prednicarbate 0.25% ointment
Intervention Description
0.25% (2.5 mg/g) of the active ingredient prednicarbate as ointment
Intervention Type
Drug
Intervention Name(s)
Clobetasol 0.05% ointment
Intervention Description
0.05% (0.5 mg/g) of the active ingredient clobetasol as ointment
Intervention Type
Drug
Intervention Name(s)
Calcipotriene 0.005% ointment
Intervention Description
0.005% (0.05 mg/g) of the active ingredient calcipotriene as ointment
Intervention Type
Drug
Intervention Name(s)
Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment
Intervention Description
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
Primary Outcome Measure Information:
Title
Baseline-corrected area under the curve of the psoriatic infiltrate thickness (PIT) measured by 20 MHz B mode ultrasound
Description
Assessment was done on the test fields on psoriatic plaques
Time Frame
Prior to drug application from Day 1 and up to Day 29
Secondary Outcome Measure Information:
Title
Skin thickness measurement of occluded test field on non-lesional skin (mean of triplicate measurement)
Description
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Time Frame
Prior to drug application from Day 1 up to Day 60
Title
Clinical assessment of atrophy using a 5-point score
Description
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Time Frame
Prior to drug application from Day 1 and up to Day 29
Title
Clinical assessment of telangiectasia using a 5-point score
Description
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Time Frame
Prior to drug application from Day 1 and up to Day 29
Title
Clinical assessment of local tolerability using a 5-point score
Description
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Time Frame
Prior to drug application from Day 1 and up to Day 29
Title
PIT measured by 20 MHz B mode ultrasound
Description
Assessment was done on the test fields on psoriatic plaques
Time Frame
Prior to drug application from Day 1 and up to Day 29
Title
Measurement of erythema using chromametry (mean of triplicate measurement)
Description
Assessment was done on the test fields on psoriatic plaques
Time Frame
Prior to drug application from Day 1 and up to Day 29
Title
Clinical efficacy assessment of the skin in the test fields using a 5-point score
Description
Assessment was done on the test fields on psoriatic plaques
Time Frame
Prior to drug application from Day 1 and up to Day 29
Title
Number of participants with adverse events
Time Frame
Approximately 64-84 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Learn more about this trial
1404003_OpenPsori.PlaqueTest to Eval.Eff.of Diff.Comp. to Mapracorat
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