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

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ClinicalTrials.gov Identifier: NCT03399526
Recruitment Status : Completed
First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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.


Condition or disease Intervention/treatment Phase
Psoriasis 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 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 11, 2013
Actual Primary Completion Date : May 31, 2013
Actual Study Completion Date : May 31, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399526


Locations
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Germany
Hamburg, Germany, 20095
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03399526     History of Changes
Other Study ID Numbers: 16599
2012-004171-39 ( EudraCT Number )
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Clobetasol
Prednicarbate
Prednisolone
Calcipotriene
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances