Phase 3
N=25
Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects
Infection
Bottom Line
View on ClinicalTrials.gov: NCT00608959 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcome: Primary: Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours — -1.91; -1.87 log 10 CFU/cm sq — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- omiganan 1% gel (Drug); chlorhexidine 2% solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cadence Pharmaceuticals
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours |
-1.91; -1.87 | <0.001 sig |
| PRIMARY Change in Mean Number of Skin Bacterial Counts From Baseline to 7 Days |
-1.44 | — |
| PRIMARY Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs) |
0; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT00608959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.