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

NCT03399526 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-01-16

No results posted yet for this study

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

Interventions

DRUG

Mapracorat (ZK 245186, BAY 86-5319)

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

DRUG

Prednicarbate 0.25% ointment

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

DRUG

Clobetasol 0.05% ointment

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

DRUG

Calcipotriene 0.005% ointment

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

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-11
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03399526 on ClinicalTrials.gov