A Phase I Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers

September 24, 2008 updated by: Zalicus

A Phase I, Single-Center, Randomized, Vehicle-Controlled Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers

This will be a phase I, single center, randomized, vehicle-controlled, blinded study comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1% mometasone) and placebo (the active ingredient free vehicle cream of CRx-197)in healthy volunteers.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Muenster, Germany
        • Proinnovera GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
  • Subject must be 18 to 60 years of age
  • Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test fields
  • Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
  • Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen. A highly effective method of birth control is defined as those which result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner.

Exclusion Criteria:

  • Suntan, hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields
  • Dark skinned persons whose skin color prevents ready assessment of skin reactions
  • 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, TSH less than LLN, or subject receiving any thyroid medication
  • Severe liver disease - ALT laboratory value that exceeds 1.5x ULN
  • Inflammatory dermatoses (e.g., atopic dermatoses/eczema, psoriasis)
  • Any skin condition involving the test fields including but not limited to bacterial, viral, or fungal skin infections, acne, rosacea
  • Active varicella, tuberculosis, syphilis or post-vaccine reactions
  • Autoimmune disease (e.g., lupus erythematosis)
  • Known allergic reactions or hypersensitivity to any of the components of the study treatments
  • Allergy to adhesives on the patches used for occlusion in the study
  • UV therapy or significant UV exposure in the four weeks before treatment application
  • 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 treatment application that may influence the outcome of the study
  • Positive for HIV antibody
  • Systemic treatments in the four weeks prior to treatment application that may interact with any of the study drugs, such as: Glucocorticoids, MAO inhibitors, anti-depressants, anti-seizure medications, anti-psychotics and anti-histamines
  • Subjects who require medications that inhibit the CYP450 2D6 pathway such as:Quinidine, Cimetidine, Type 1 anti-arrhythmic, Phenothiazines, Selective serotonin reuptake inhibitors, Reserpine, other anticholinergic drugs, and sympathomimetic drugs
  • Treatment with any investigational agent within one month before treatment application for this trial
  • Female subject who is pregnant , lactating, or with a positive pregnancy test
  • 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, make the subject unsuitable for enrollment
  • Subject is institutionalized because of legal or regulatory order

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CRx-197 high dose (0.1% nortriptyline HCl + 0.3% loratadine)
Topical
EXPERIMENTAL: CRx-197 low dose (0.1% nortriptyline HCl + 0.1% loratadine)
Topical
EXPERIMENTAL: 0.1% nortriptyline HCl
Topical
ACTIVE_COMPARATOR: 0.1% mometasone furoate
Topical
PLACEBO_COMPARATOR: Active ingredient free vehicle cream of CRx-197
Topical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of CRx-197 as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus.
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in change from baseline in psoriatic infiltrate measured by ultrasound between CRx-197, nortriptyline, active comparator as well as vehicle of CRx-197 and untreated test field(s)
Time Frame: Days 8, 15, 22, 29 and 43
Days 8, 15, 22, 29 and 43
Difference in change from baseline in erythema measured by chronometry between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) and normal skin
Time Frame: Days 8, 15, 22, 29 and 43
Days 8, 15, 22, 29 and 43
Modified PASI between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s)
Time Frame: Baseline, and Days 8, 15, 22, 29 and 43
Baseline, and Days 8, 15, 22, 29 and 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Jutta Harten, MD, Proinnovera GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

July 21, 2008

First Submitted That Met QC Criteria

July 23, 2008

First Posted (ESTIMATE)

July 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 26, 2008

Last Update Submitted That Met QC Criteria

September 24, 2008

Last Verified

September 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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