This will be a phase 2a single-center, randomized, blinded, vehicle-controlled exploratory study to assess the activity and safety of CRx-197 in subjects with plaque psoriasis. Approximately 20 male or female subjects with chronic plaque type psoriasis, 18 to 70 years of age, will be included in this study. All subjects with stable psoriatic plaques will receive all of the following treatments each in a separate test field, once each day for four weeks under occlusion: * CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine) * CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine) * 0.1% nortriptyline HCl topical cream * 0.005% calcipotriol topical cream * Vehicle of CRx-197 topical cream (placebo)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)
CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine)
0.1% nortriptyline HCl topical cream
0.005% calcipotriol topical cream
Vehicle of CRx-197 topical cream (placebo)
ProInnovera
Münster, Germany
Safety and tolerability as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus
Time frame: 6 weeks
Difference in change from baseline in psoriatic infiltrate measured by ultrasound at Days 8, 15, 22, 29 and 43 between CRx-197, nortriptyline, active comparator as well as vehicle of CRx-197 and untreated test field(s)
Time frame: 6 weeks
Differences in change from baseline in erythema measured by chromametry at Days 8, 15, 22, 29 and 43 between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) and normal skin
Time frame: 6 weeks
Modified PASI at Baseline, and Days 8, 15, 22, 29 and 43 between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s)
Time frame: 6 weeks
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