Clinical trial NCT03399526 (phase 1, status: completed)
Conditions: psoriasis
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50
Drugs: mapracorat (zk 245186, bay 86-5319), prednicarbate 0.25% ointment, clobetasol 0.05% ointment, calcipotriene 0.005% ointment, calcipotriene 0.005%/betamethasone dipropionate 0.05% ointment
SMILES: CC1=CC=C2C(NC[C@](O)(CC(C)(C)C3=CC(F)=CC4=C3OCC4)C(F)(F)F)=CC=CC2=N1, [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, [H][C@@]12C[C@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, O[C@H](\C=C\[C@@H](C)[C@@]1([H])CC[C@@]2([H])\C(CCC[C@]12C)=C\C=C1\C[C@@H](O)C[C@H](O)C1=C)C1CC1, O[C@H](\C=C\[C@@H](C)[C@@]1([H])CC[C@@]2([H])\C(CCC[C@]12C)=C\C=C1\C[C@@H](O)C[C@H](O)C1=C)C1CC1
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