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

Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608959
• Other study ID #: CPI-226-301
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2008
• Last updated: January 22, 2010
• Start date: May 2008
• Est. completion date: June 2008

Study information

• Verified date: January 2010
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	BioSciences Lab	Bozeman	Montana

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

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