drugset / Trial / NCT00796211

A Single-Center Exploratory Study to Assess the Activity of CRx-197-002 in Plaque Psoriasis

NCT00796211

Phase 2 Completed 20 enrolled Zalicus
RandomizedParallel-groupTriple-blindTreatment

Summary

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)

Timeline

Start
2008-11
Primary completion
2008-12
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Calcipotriol Small molecule 0.005 % Topical
Subject Loratadine Small molecule 0.1 % Topical
Subject Loratadine Small molecule 0.3 % Topical
Comparator Nortriptyline Small molecule 0.1 % Topical

Indications