Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by:
Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00608959
First received: January 23, 2008
Last updated: January 22, 2010
Last verified: January 2010
  Purpose

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).


Condition Intervention Phase
Infection
Drug: omiganan 1% gel
Drug: chlorhexidine 2% solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Single- Center, Open-Label, Study of the Persistence of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Cadence Pharmaceuticals:

Primary Outcome Measures:
  • Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours [ Time Frame: Prior to first application (0 hours) to 72 hours post application ] [ Designated as safety issue: No ]
  • Change in Mean Number of Skin Bacterial Counts From Baseline to 7 Days [ Time Frame: Prior to first application (0 hours) to 7 days post application. ] [ Designated as safety issue: No ]
  • Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs) [ Time Frame: Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days. ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: omiganan 1% gel
Omiganan has a rapid bactericidal and fungicidal effect which is under development for the prevention of infections arising from short-term central venous catheters, as well as for the prevention of surgical wound infections in contaminated wounds.
Drug: omiganan 1% gel

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.

Active Comparator: chlorhexidine 2% Drug: chlorhexidine 2% solution

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.


Detailed Description:

The study is comprised of 2 parts with approximately 20 subjects participating in each part.

Subjects eligible for Part 1 will have omiganan 1 % gel applied to 6 sites across the chest and/or abdomen and chlorhexidine 2% solution will be applied to 6 matching sites on the contralateral side.

Subjects eligible for Part 2 will each have omiganan 1% gel applied to 6 sites across the upper chest or abdomen.In addition,subjects in Part 2 will have 2 peripheral catheters inserted, one in each arm.One catheter insertion site will be treated with omiganan 1% gel (following treatment with isopropyl alcohol) and the other site will be treated with chlorhexidine 2%/isopropyl alcohol.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608959

Locations
United States, Montana
BioSciences Lab
Bozeman, Montana, United States, 59715
Sponsors and Collaborators
Cadence Pharmaceuticals
Investigators
Study Director: Catherine J Hardalo, MD Cadence Pharmaceuticals
  More Information

No publications provided

Responsible Party: Catherine Hardalo, MD. Vice President, Anti Infectives Clinical Development, Cadence Pharmaceuticals,Inc.
ClinicalTrials.gov Identifier: NCT00608959     History of Changes
Other Study ID Numbers: CPI-226-301
Study First Received: January 23, 2008
Results First Received: June 30, 2009
Last Updated: January 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Cadence Pharmaceuticals:
Skin colonization
Catheter colonization
Catheter site infection

Additional relevant MeSH terms:
Chlorhexidine gluconate
Anti-Infective Agents
Chlorhexidine
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on July 20, 2014