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

NCT03399526 | Completed Phase 1

• 2 other identifiers: 165992012-004171-39
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Skin thickness measurement of occluded test field on non-lesional skin (mean of triplicate measurement)

  Prior to drug application from Day 1 up to Day 60

• Clinical assessment of atrophy using a 5-point score

  Prior to drug application from Day 1 and up to Day 29

• Clinical assessment of telangiectasia using a 5-point score

  Prior to drug application from Day 1 and up to Day 29

• Clinical assessment of local tolerability using a 5-point score

  Prior to drug application from Day 1 and up to Day 29

• PIT measured by 20 MHz B mode ultrasound

  Prior to drug application from Day 1 and up to Day 29

Study Arms (5)

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

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

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

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

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

Drug: Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment

Interventions

Mapracorat (ZK 245186, BAY 86-5319) DRUG

0.1% (1 mg/g) of the active ingredient mapracorat plus excipients as ointment

Mapracorat

Prednicarbate 0.25% ointment DRUG

0.25% (2.5 mg/g) of the active ingredient prednicarbate as ointment

Prednicarbate

Clobetasol 0.05% ointment DRUG

0.05% (0.5 mg/g) of the active ingredient clobetasol as ointment

Clobetasol

Calcipotriene 0.005% ointment DRUG

0.005% (0.05 mg/g) of the active ingredient calcipotriene as ointment

Calcipotriene

Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment DRUG

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

Calcipotriene/Betamethasone dipropionate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Hamburg, 20095, Germany

Location

Related Links

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

MeSH Terms

Conditions

Psoriasis

Interventions

R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol; prednicarbate; Ointments; Clobetasol; calcipotriene; betamethasone-17,21-dipropionate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic 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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 16, 2018
• Study Start: February 11, 2013
• Primary Completion: May 31, 2013
• Study Completion: May 31, 2013
• Last Updated: January 16, 2018

Record last verified: 2017-12

Locations

DE (1)