NCT00796211

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

A Single-Center, Randomized, Blinded, Vehicle- Controlled Exploratory Study to Assess the Activity of CRx-197 in Subjects With Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zalicus · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	CRx-197	CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)
DRUG	CRx-197	CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine)
DRUG	Nortriptyline	0.1% nortriptyline HCl topical cream
DRUG	Calcipotriol	0.005% calcipotriol topical cream
OTHER	Placebo	Vehicle of CRx-197 topical cream (placebo)

Timeline

• Start date: 2008-11-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2008-11-24
• Last updated: 2009-01-15

Locations

1 site across 1 country: Germany