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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399526
• Other study ID #: 16599
• Secondary ID: 2012-004171-39
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2018
• Last updated: January 9, 2018
• Start date: February 11, 2013
• Est. completion date: May 31, 2013

Study information

• Verified date: December 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 31, 2013
• Est. primary completion date: May 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Mapracorat (ZK 245186, BAY 86-5319)
0.1% (1 mg/g) of the active ingredient mapracorat plus excipients as ointment
• Prednicarbate 0.25% ointment
0.25% (2.5 mg/g) of the active ingredient prednicarbate as ointment
• Clobetasol 0.05% ointment
0.05% (0.5 mg/g) of the active ingredient clobetasol as ointment
• Calcipotriene 0.005% ointment
0.005% (0.05 mg/g) of the active ingredient calcipotriene as ointment
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prior to drug application from Day 1 and up to Day 29
Secondary	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	Prior to drug application from Day 1 up to Day 60
Secondary	Clinical assessment of atrophy using a 5-point score	Assessment was made on occluded test fields on non-lesional skin areas on the forearm	Prior to drug application from Day 1 and up to Day 29
Secondary	Clinical assessment of telangiectasia using a 5-point score	Assessment was made on occluded test fields on non-lesional skin areas on the forearm	Prior to drug application from Day 1 and up to Day 29
Secondary	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	Prior to drug application from Day 1 and up to Day 29
Secondary	PIT measured by 20 MHz B mode ultrasound	Assessment was done on the test fields on psoriatic plaques	Prior to drug application from Day 1 and up to Day 29
Secondary	Measurement of erythema using chromametry (mean of triplicate measurement)	Assessment was done on the test fields on psoriatic plaques	Prior to drug application from Day 1 and up to Day 29
Secondary	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	Prior to drug application from Day 1 and up to Day 29
Secondary	Number of participants with adverse events		Approximately 64-84 days

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