CRx-191 is a proprietary synergistic combination drug candidate being evaluated by CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor- alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of psoriasis. This clinical trial will assess the effectiveness of CRx-191 in reducing the psoriatic infiltrate band thickness as measured by transdermal ultrasound. All subjects will receive all treatments in separate test fields, with intra-individual comparison of the treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Topical 0.1% mometasone furoate
Topical 0.05% or 0.1% nortriptyline HCl
Topical placebo
bioskin GmbH
Berlin, Germany
The primary efficacy endpoint is the difference in reduction from baseline in psoriatic infiltrate at Day 12 between CRx-191 and vehicle.
Time frame: Day 12
Differences in reduction from baseline in psoriatic infiltrate at Day 12 between CRx-191 and its components, mometasone furoate and nortriptyline HCI. Demonstrate tolerability and safety of CRx-191.
Time frame: Day 12
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