Clinical trial NCT03399526: 1404003_OpenPsori.PlaqueTest to Eval.Eff.of Diff.Comp. to Mapracorat
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-01-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Baseline-corrected area under the curve of the psoriatic infiltrate thickness (PIT) measured by 20 MHz B mode ultrasound
timeFrame: Prior to drug application from Day 1 and up to Day 29
Secondary outcomes:
measure: Skin thickness measurement of occluded test field on non-lesional skin (mean of triplicate measurement)
timeFrame: Prior to drug application from Day 1 up to Day 60
measure: Clinical assessment of atrophy using a 5-point score
timeFrame: Prior to drug application from Day 1 and up to Day 29
measure: Clinical assessment of telangiectasia using a 5-point score
timeFrame: Prior to drug application from Day 1 and up to Day 29
measure: Clinical assessment of local tolerability using a 5-point score
timeFrame: Prior to drug application from Day 1 and up to Day 29
measure: PIT measured by 20 MHz B mode ultrasound
timeFrame: Prior to drug application from Day 1 and up to Day 29
measure: Measurement of erythema using chromametry (mean of triplicate measurement)
timeFrame: Prior to drug application from Day 1 and up to Day 29
measure: Clinical efficacy assessment of the skin in the test fields using a 5-point score
timeFrame: Prior to drug application from Day 1 and up to Day 29
measure: Number of participants with adverse events
timeFrame: Approximately 64-84 days
Other outcomes:
Locations:
city: Hamburg
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: