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

Bayer

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment; Drug: Prednicarbate 0.25% ointment; Drug: Mapracorat (ZK 245186, BAY 86-5319); Drug: Calcipotriene 0.005% ointment; Drug: Clobetasol 0.05% ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03399526

2012-004171-39 (EudraCT Number)

16599

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 5 patient groups

Mapracorat

Experimental group

Description:

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

Treatment:

Drug: Mapracorat (ZK 245186, BAY 86-5319)

Prednicarbate

Active Comparator group

Description:

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

Treatment:

Drug: Prednicarbate 0.25% ointment

Clobetasol

Active Comparator group

Description:

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

Treatment:

Drug: Clobetasol 0.05% ointment

Calcipotriene

Active Comparator group

Description:

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

Treatment:

Drug: Calcipotriene 0.005% ointment

Calcipotriene/Betamethasone dipropionate

Active Comparator group

Description:

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

Treatment:

Drug: Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment