1404003_OpenPsori.PlaqueTest to Eval.Eff.of Diff.Comp. to Mapracorat

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Mapracorat (ZK 245186, BAY 86-5319); Drug: Prednicarbate 0.25% ointment; Drug: Clobetasol 0.05% ointment; Drug: Calcipotriene 0.005% ointment; Drug: Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20095

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mapracorat; 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	Drug: Mapracorat (ZK 245186, BAY 86-5319); 0.1% (1 mg/g) of the active ingredient mapracorat plus excipients as ointment
Active Comparator: Prednicarbate; 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	Drug: Prednicarbate 0.25% ointment; 0.25% (2.5 mg/g) of the active ingredient prednicarbate as ointment
Active Comparator: Clobetasol; 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	Drug: Clobetasol 0.05% ointment; 0.05% (0.5 mg/g) of the active ingredient clobetasol as ointment
Active Comparator: Calcipotriene; 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	Drug: Calcipotriene 0.005% ointment; 0.005% (0.05 mg/g) of the active ingredient calcipotriene as ointment
Active Comparator: Calcipotriene/Betamethasone dipropionate; 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	Drug: Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Prior to drug application from Day 1 and up to Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	Prior to drug application from Day 1 and up to Day 29
Number of participants with adverse events		Approximately 64-84 days

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2013
• Primary Completion (Actual): May 31, 2013
• Study Completion (Actual): May 31, 2013

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Micronutrients; Membrane Transport Modulators; Anti-Asthmatic Agents; Respiratory System Agents; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate; Clobetasol; Calcitriol; Prednicarbate
• Other Study ID Numbers: 16599; 2012-004171-39 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No