Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
CombinatoRx |
---|---|
Information provided by: | CombinatoRx |
ClinicalTrials.gov Identifier: | NCT00796211 |
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:
Condition | Intervention | Phase |
---|---|---|
Plaque Psoriasis |
Drug: CRx-197 Drug: Nortriptyline Drug: Calcipotriol Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Single-Center, Randomized, Blinded, Vehicle- Controlled Exploratory Study to Assess the Activity of CRx-197 in Subjects With Plaque Psoriasis |
Estimated Enrollment: | 20 |
Study Start Date: | November 2008 |
Study Completion Date: | January 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)
|
Drug: CRx-197
CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)
|
2: Experimental
CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine)
|
Drug: CRx-197
CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine)
|
3: Active Comparator
0.1% nortriptyline HCl topical cream
|
Drug: Nortriptyline
0.1% nortriptyline HCl topical cream
|
4: Active Comparator
0.005% calcipotriol topical cream
|
Drug: Calcipotriol
0.005% calcipotriol topical cream
|
5: Placebo Comparator
Vehicle of CRx-197 topical cream (placebo)
|
Other: Placebo
Vehicle of CRx-197 topical cream (placebo)
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | CombinatoRx ( Alka Batycky, Executive Director, Clinical Programs ) |
Study ID Numbers: | CRx-197-002 |
Study First Received: | November 21, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00796211 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Psoriasis CRx-197 nortriptyline loratadine |
CombinatoRx Dermatology Erythema Pruritus |
Calcipotriene Pruritus Erythema Loratadine |
Skin Diseases Psoriasis Nortriptyline Skin Diseases, Papulosquamous |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs |
Pharmacologic Actions Antidepressive Agents, Tricyclic Therapeutic Uses Central Nervous System Agents Dermatologic Agents Antidepressive Agents |