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

Sponsored by:	Cadence Pharmaceuticals
Information provided by:	Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00608959

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 III

Drug Information available for: Chlorhexidine Chlorhexidine digluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Factorial Assignment
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

Further study details as provided by Cadence Pharmaceuticals:

Primary Outcome Measures:

The primary efficacy endpoint is the change in the mean number of skin bacterial counts from baseline to 72 hours after application of study drug [ Time Frame: 72 hours after application of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Analyses of skin irritation scores for erythema, edema,rash/pruritis, and dryness will be assessed to evaluate changes. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment:	50
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
omiganan 1% gel: Experimental 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 IV catheter.
chlorhexidine 2%: Active Comparator	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: In addition, subjects in Part 2 will have chlorhexidine 2% solution applied to one IV catheter.

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 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

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

Responsible Party:	Cadence Pharmaceuticals,Inc. ( Catherine Hardalo, MD. Vice President, Anti Infectives Clinical Development )
Study ID Numbers:	CPI-226-301
Study First Received:	January 23, 2008
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00608959
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cadence Pharmaceuticals:

Skin colonization
Catheter colonization
Catheter site infection

Study placed in the following topic categories:

Chlorhexidine
Chlorhexidine gluconate
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Therapeutic Uses

Infection
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009