- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00721331
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
Status
Completed
Conditions
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
-
-
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Muenster, Germany
- Proinnovera GmbH
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-
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)
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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
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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
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Days 8, 15, 22, 29 and 43
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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
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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
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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
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Dermatitis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Dermatologic Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Histamine H1 Antagonists, Non-Sedating
- Adrenergic Uptake Inhibitors
- Mometasone Furoate
- Nortriptyline
- Loratadine
Other Study ID Numbers
- CRx-197-001
- EudraCT # 2008-000611-15
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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