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Phase I Study of Topical CRx-191 in Normal Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00544687
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : November 15, 2007
Information provided by:

Tracking Information
First Submitted Date  ICMJE October 15, 2007
First Posted Date  ICMJE October 16, 2007
Last Update Posted Date November 15, 2007
Study Start Date  ICMJE September 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2007)
Full skin thinning produced by treatment of CRx-191 in comparison with its components at corresponding dose levels, and vehicle with a marketed corticosteriod. Assess tolerability and safety of CRx-191. [ Time Frame: 28 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase I Study of Topical CRx-191 in Normal Healthy Volunteers
Official Title  ICMJE A Phase I, Single-Center, Randomized, Vehicle and Active-Controlled Study to Assess and Compare the Atrophy-Causing Potential of Topical CRx-191 Formulations in Healthy Volunteers
Brief Summary CRx-191 is a proprietary synergistic combination drug candidate being evaluated by CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor- alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of psoriasis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: CRx-191
    topical (mometasone furoate + nortriptyline HCl)
  • Drug: mometasone furoate
    topical mometasone furoate
  • Drug: nortriptyline HCl
    topical nortriptyline HCl
  • Drug: Karison® Creme
    topical Karison® Creme (clobetasol-17-propinate 0.05%)
  • Drug: Vehicle
    topical (placebo)
Study Arms  ICMJE
  • Experimental: 1
    CRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl)
    Intervention: Drug: CRx-191
  • Experimental: 2
    CRx-191 (0.1% mometasone furoate + 0.1% nortriptyline HCl)
    Intervention: Drug: CRx-191
  • Active Comparator: 3
    0.1% mometasone furoate
    Intervention: Drug: mometasone furoate
  • Active Comparator: 4
    0.1% nortriptyline HCl
    Intervention: Drug: nortriptyline HCl
  • Active Comparator: 5
    Karison® Creme (clobetasol-17-propinate 0.05%)
    Intervention: Drug: Karison® Creme
  • Placebo Comparator: 6
    Vehicle (placebo)
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2007)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must voluntarily give written informed consent
  • Subject must be at least 18 years of age
  • Subject must have healthy skin on which reddening can be easily recognized in the area of the test 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; systemic contraceptive (combined oral contraceptive, implant, injection), or safe intrauterine device (IUD)
  • Written informed consent obtained

Exclusion Criteria:

  • Acne, suntan, eczema, hyper- or hypopigmentation, or tattoos in 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 < LLN, or receiving thyroid medication
  • Severe liver disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values that exceed 1.5x ULN)
  • Inflammatory dermatoses (e.g. atopic dermatitis, psoriasis), bacterial, viral, or fungal skin infections; facial 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 preparations
  • Allergy to adhesives on the patches used for occlusion 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 human immunodeficiency virus (HIV) antibody
  • 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
  • Subjects who require medications that inhibit the cytochrome P450 (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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00544687
Other Study ID Numbers  ICMJE CRx-191-002
EudraCT Number: 2006-005903-33
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Zalicus
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Johannes Gassmueller, M.D. Bioskin GmbH
PRS Account Zalicus
Verification Date November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP