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

NCT00796211 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-01-15

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Zalicus

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00796211 on ClinicalTrials.gov