Study Completed

Psoriasis

Bayer Identifier:

16599

ClinicalTrials.gov Identifier:

NCT03399526

EudraCT Number:

2012-004171-39

EU CT Number:

Not Available

1404003_OpenPsori.PlaqueTest to eval.Eff.of diff.Comp. to Mapracorat

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years

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

Trial summary

Enrollment Goal

Trial Dates

February 2013 - May 2013

Phase

Phase 1

Could I Receive a placebo

Products

Mapracorat (BAY86-5319)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Hamburg, 20095, Germany

Primary Outcome

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
Time Frame:
Prior to drug application from Day 1 and up to Day 29
Safety Issue:
No

Secondary Outcome

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
Time Frame:
Prior to drug application from Day 1 up to Day 60
Safety Issue:
No
Clinical assessment of atrophy using a 5-point score
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Time Frame:
Prior to drug application from Day 1 and up to Day 29
Safety Issue:
No
Clinical assessment of telangiectasia using a 5-point score
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Time Frame:
Prior to drug application from Day 1 and up to Day 29
Safety Issue:
No
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
Time Frame:
Prior to drug application from Day 1 and up to Day 29
Safety Issue:
No
PIT measured by 20 MHz B mode ultrasound
Assessment was done on the test fields on psoriatic plaques
Time Frame:
Prior to drug application from Day 1 and up to Day 29
Safety Issue:
No
Measurement of erythema using chromametry (mean of triplicate measurement)
Assessment was done on the test fields on psoriatic plaques
Time Frame:
Prior to drug application from Day 1 and up to Day 29
Safety Issue:
No
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
Time Frame:
Prior to drug application from Day 1 and up to Day 29
Safety Issue:
No
Number of participants with adverse events
Time Frame:
Approximately 64-84 days
Safety Issue:
Yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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