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OpenTrials
Completed

NCT Number: NCT03399526

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hamburg, 20095, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mapracorat (ZK 245186, BAY 86-5319)

Drug

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

Prednicarbate 0.25% ointment

Drug

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

Clobetasol 0.05% ointment

Drug

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

Calcipotriene 0.005% ointment

Drug

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

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Assessment was made on occluded test fields on non-lesional skin areas on the forearm

  2. Clinical assessment of atrophy using a 5-point score

    Time frame: Prior to drug application from Day 1 and up to Day 29

    Assessment was made on occluded test fields on non-lesional skin areas on the forearm

  3. Clinical assessment of telangiectasia using a 5-point score

    Time frame: Prior to drug application from Day 1 and up to Day 29

    Assessment was made on occluded test fields on non-lesional skin areas on the forearm

  4. Clinical assessment of local tolerability using a 5-point score

    Time frame: Prior to drug application from Day 1 and up to Day 29

    Assessment was made on occluded test fields on non-lesional skin areas on the forearm

  5. 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

  6. Measurement of erythema using chromametry (mean of triplicate measurement)

    Time frame: Prior to drug application from Day 1 and up to Day 29

    Assessment was done on the test fields on psoriatic plaques

  7. 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

    Assessment was done on the test fields on psoriatic plaques

  8. Number of participants with adverse events

    Time frame: Approximately 64-84 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 16, 2018
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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