Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects
Condition: Infection
MeSH terms: Infections
Intervention: omiganan 1% gel; chlorhexidine 2% solution
Intervention description: Omiganan 1% gel will be applied to 6 sites on the chest and/or abdomen.Swab cultures will be obtained at specified timepoints over a period of 3 days (Part1) or 7 days (Part 2).
In addition, subjects in Part 2 will have omiganan 1% gel applied to one intravenous (IV) catheter site.; Part 1- chlorhexidine 2% solution will be applied to 6 sites on the chest and/or abdomen. All application sites will be covered with semi-transparent dressings.Swab cultures will be obtained at specific timepoints over a period of 3 days.
Part 2: Subjects in Part 2 will have chlorhexidine 2% solution applied to one intravenous (IV) catheter site only.
Intervention MeSH terms: Chlorhexidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Skin colonization; Catheter colonization; Catheter site infection

Summary:

      The purpose of this research study is to determine if omiganan 1% gel (the investigational
      medication in this research study) is effective and safe when compared to chlorhexidine 2%
      (an FDA approved medication) for killing bacteria (germs) that live on the surface of the
      skin. Both of the study medications are applied topically (on the surface of the skin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects18-70 years of age

          -  No evidence of dermatosis, dermatitis, inflammation, scarring, or acute injuries to
             the drug application sites on the chest or abdomen

          -  Subjects must have screening samples from the skin on the right and left side of the
             chest or abdomen containing at least 2.5 log10 colony forming units per square
             centimeter (CFU/cm2 )organisms (from the average of 2 samples obtained during
             screening)

          -  Willing to provide written informed consent.

        Exclusion Criteria:

          -  Allergies or sensitivities to alcohol, adhesive tape, bandages, latex, chlorhexidine
             gluconate, or any of the ingredients of omiganan 1% gel

          -  Prior treatment with any systemic antibiotic, or any other product known to affect the
             normal microbial flora of the skin within 7 days of the screening examination

          -  Requirement for topical antibiotic use on or within 10 cm of any study test site

          -  Subjects who have been treated with any investigational drug (other than omiganan)
             within the previous 30 days, or who are participating in an investigational drug study
             at any time during the course of this study

          -  Subjects who have been previously treated with omiganan and experienced a possibly
             related adverse event during the study Note: a wash out period of one week is required
             prior to participation in Part 2 of the study

          -  A medical condition that the Investigator believes may interfere with the safety of
             the subject or the intent and conduct of the study Note: this includes conditions such
             as: severe eczema, psoriasis and/or dermal infections, old scars, insulin dependent
             diabetes mellitus, severe immunocompromising conditions, HIV infection, or use of
             medications that would interfere with assessment of study endpoints

          -  A current or recent history of illicit drug or alcohol abuse

          -  Subjects not willing or able to fulfill protocol requirements

          -  Pregnancy. Women of childbearing potential who have a positive or equivocal result on
             a urine and/or blood pregnancy test before study enrollment will not be included