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

This study has been completed.
Sponsor:
Information provided by:
Zalicus
ClinicalTrials.gov Identifier:
NCT00796211
First received: November 21, 2008
Last updated: January 14, 2009
Last verified: January 2009
  Purpose

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)

Condition Intervention Phase
Plaque Psoriasis
Drug: CRx-197
Drug: Nortriptyline
Drug: Calcipotriol
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-Center, Randomized, Blinded, Vehicle- Controlled Exploratory Study to Assess the Activity of CRx-197 in Subjects With Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Zalicus:

Primary Outcome Measures:
  • Safety and tolerability as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Difference in change from baseline in psoriatic infiltrate measured by ultrasound at Days 8, 15, 22, 29 and 43 between CRx-197, nortriptyline, active comparator as well as vehicle of CRx-197 and untreated test field(s) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Differences in change from baseline in erythema measured by chromametry at Days 8, 15, 22, 29 and 43 between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) and normal skin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Modified PASI at Baseline, and Days 8, 15, 22, 29 and 43 between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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
Experimental: 1
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)
Experimental: 2
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)
Active Comparator: 3
0.1% nortriptyline HCl topical cream
Drug: Nortriptyline
0.1% nortriptyline HCl topical cream
Active Comparator: 4
0.005% calcipotriol topical cream
Drug: Calcipotriol
0.005% calcipotriol topical cream
Placebo Comparator: 5
Vehicle of CRx-197 topical cream (placebo)
Other: Placebo
Vehicle of CRx-197 topical cream (placebo)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • I01 Subject must voluntarily sign and date the written informed consent prior to any study specific procedures
  • I02 Subject must be 18 to 70 years of age
  • I03 Subject must have chronic plaque psoriasis and plaque infiltrates of a thickness of a minimum of 150 µm and stable plaques in an area sufficient for up to five test fields and an untreated control field per each plaque
  • I04 Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
  • I05 Females of childbearing potential age should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen.

Exclusion Criteria:

  • E01 Erythrodermic, guttate or pustular psoriasis
  • E02 Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias or valvular heart disease
  • E03 Mania or acute delirium or epilepsy
  • E04 Narrow angle glaucoma
  • E05 Hyperthyroidism by medical history, TSH less than LLN, or a subject receiving thyroid medication
  • E06 Diabetes
  • E07 Intolerance to lidocaine
  • E08 Severe liver disease [ALT laboratory value that exceeds 2.5x ULN]
  • E09 Known severe kidney disease, acute urinary retention, prostatic hypertrophy with post void residual urine or laboratory value of creatinine that exceeds 1.5x ULN
  • E10 Significant gastrointestinal disease including but not limited to pyloric stenosis or paralytic ileus
  • E11 Inflammatory dermatoses except psoriasis; bacterial, viral, or fungal skin infections (at the test plaques); facial rosacea
  • E12 Active varicella, tuberculosis, syphilis or post-vaccine reactions
  • E13 Autoimmune disease other than plaque psoriasis (e.g., lupus erythematosis)
  • E14 Known allergic reactions or hypersensitivity to any of the components of the study treatments
  • E15 Allergy to adhesives on the templates used in this study
  • E16 UV therapy or significant UV exposure in the four weeks before treatment application
  • E17 History of malignancy (except for treated or excised basal cell carcinoma)
  • E18 History of drug or alcohol abuse (as defined by the Investigator)
  • E19 Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study
  • E20 Subject with demonstrated hypercalcemia (calcium greater than ULN) or evidence of Vitamin D toxicity
  • E21 Subject with demonstrated hypokalemia (less than LLN)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796211

Locations
Germany
ProInnovera
Muenster, Germany
Sponsors and Collaborators
Zalicus
  More Information

No publications provided

Responsible Party: Alka Batycky, Executive Director, Clinical Programs, CombinatoRx
ClinicalTrials.gov Identifier: NCT00796211     History of Changes
Other Study ID Numbers: CRx-197-002
Study First Received: November 21, 2008
Last Updated: January 14, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Zalicus:
Psoriasis
CRx-197
nortriptyline
loratadine
CombinatoRx
Dermatology
Erythema
Pruritus

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Nortriptyline
Loratadine
Calcipotriene
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on July 20, 2014