CompletedPhase 3

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

United States30 participantsStarted 2008-05

Plain-language 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).

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: thi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours

Timeframe: Prior to first application (0 hours) to 72 hours post application

Change in Mean Number of Skin Bacterial Counts From Baseline to 7 Days

Timeframe: Prior to first application (0 hours) to 7 days post application.

Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs)

Timeframe: Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days.

Trial details

NCT IDNCT00608959

SponsorCadence Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-06

Results submitted2009-06-30

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