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A Single-Center, Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Activity of CRx-191 in Reducing the Psoriatic Infiltrate Band Thickness in Plaque Psoriasis


Phase 2
18 Years
70 Years
Not Enrolling
Both
Plaque Psoriasis

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Trial Information

A Single-Center, Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Activity of CRx-191 in Reducing the Psoriatic Infiltrate Band Thickness in Plaque Psoriasis


Inclusion Criteria:



- Subject must voluntarily give written informed consent

- Subject must be between 18 and 70 years of age

- Subject must have chronic plaque psoriasis and stable plaques in an area sufficient
for six treatment fields

- The physical examination must be without disease findings unless the investigator
considers an abnormality to be irrelevant to the outcome of the study

- Sexually active females of childbearing potential should either be surgically sterile
(hysterectomy or tubal ligation), or should use a highly effective medically accepted
contraceptive regimen

Exclusion Criteria:

- Erythrodermic, guttate or pustular psoriasis

- Cardiac disease, including recent myocardial infarction, any degree of heart block or
other cardiac arrhythmias and valvular heart disease

- Mania

- Narrow angle glaucoma

- Hyperthyroidism by medical history, thyroid stimulating hormone (TSH) less than lower
limit of normal (LLN), or receiving thyroid medication

- Intolerance to Lidocaine

- Severe liver disease (alanine aminotransferase (ALT) or aspartate aminotransferase
(AST) laboratory values that exceed 1.5x upper limit of normal (ULN))

- Inflammatory dermatoses except psoriasis; bacterial, viral and fungal skin
infections; facial rosacea

- Active varicella, tuberculosis, syphilis or post-vaccine reaction

- Autoimmune disease other than plaque psoriasis (e.g. lupus erythematosis and
psoriatic arthritis)

- Known allergic reactions or hypersensitivity to any of the components of the study
preparations

- Allergy to adhesives on the hydrocolloid dressing used in this study

- UV therapy in the four weeks before the study

- History of malignancy (except for treated or excised basal cell carcinoma)

- Surgery within the previous 3 months (except for minor cosmetic or dental procedures)

- History of drug or alcohol abuse (as defined by the Investigator)

- Symptoms of a clinically significant illness in the four weeks before the study that
may influence the outcome of the study

- Positive for HIV antibody

- Subjects who require systemically acting medications for the treatment of psoriasis
which might counter or influence the study objectives such as: Methotrexate;
Cyclosporine; Anti-TNF╬▒ therapies

- Subjects who require medications that inhibit the CYP450 2D6 pathway such as:
Quinidine; Cimetidine; Type 1 antiarrhythmics; Phenothiazines; Selective serotonin
reuptake inhibitors such as fluoxetine, paroxetine, and sertraline; Reserpine, other
anticholinergic drugs, and sympathomimetic drugs

- Topical treatments for psoriasis (except for salicylic acid in vaseline) in the four
weeks preceding and during the study (topical corticosteroids disallowed for eight
weeks prior to the study)

- Systemic treatments in the two weeks preceding and during the study that may interact
with any of the study drugs, such as: Glucocorticoids (po, im, iv); MAO inhibitors;
Anti-depressants; Anti-seizure medications; Anti-psychotics; Antihistamines

- Treatments in the two weeks preceding and during the study that may aggravate
psoriasis, such as: Anti-malarials; Beta-blockers

- Participation in another clinical trial and/or treatment received with any
investigational agent within one month before the initial dose of study medication

- Female subject who is pregnant or lactating

- Significant UV exposure in the four weeks before the study

- Unwilling or unable to comply with the requirements of this protocol, including the
presence of any condition (physical, mental, or social) that is likely to affect the
subject's return for follow-up visits on schedule

- Other unspecified reasons that, in the opinion of the Investigator or sponsor make
the subject unsuitable for enrollment

- Subject is institutionalized because of legal or regulatory order

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

The primary efficacy endpoint is the difference in reduction from baseline in psoriatic infiltrate at Day 12 between CRx-191 and vehicle.

Outcome Time Frame:

Day 12

Safety Issue:

No

Principal Investigator

Johannes Gassmueller, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bioskin GmbH

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CRx-191-001

NCT ID:

NCT00557739

Start Date:

November 2007

Completion Date:

January 2008

Related Keywords:

  • Plaque Psoriasis
  • CRx-191
  • Plaque
  • Psoriasis
  • nortriptyline hydrochloride
  • mometasone furoate
  • psoriatic infiltrate
  • Psoriasis

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