Trial · NCT00608959
Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects
NCT00608959, Phase 3, Completed, Cadence Pharmaceuticals; results first posted 2010-01-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects. Trials, record NCT00608959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00608959
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects
- NCT number
- NCT00608959
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Cadence Pharmaceuticals
- Conditions
- Infection
- Interventions
- omiganan 1% gel, chlorhexidine 2% solution
- First posted
- 2008-02-06
- Last updated
- 2010-01-26
- Results first posted
- 2010-01-25
- Limitations and caveats
FDA reviewer noted that there were multiple endpoints that required multiplicity adjustments to control for the overall type I error rate.Based on feedback the 72 hour endpoint was selected for Part 2 as the primary efficacy endpoint.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Change in the mean number of skin bacterial counts (CFU/cm2) which was calculated by subtracting log10 CFU/cm2 at 72 hours (single sample per subject per timepoint) from the log10 CFU/cm2 at 0 hours (baseline) in Part 2.Baseline was calculated by 'pooling' samples from 6 sites adjacent to each timepoint. |
| 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. | Change in the mean number of skin bacterial counts (log 10 CFU/cm2)which was calculated by subtracting log10 CFU/cm2 at 7 days (one sample per site per subject per timepoint) from log10CFU/cm2 at 0 hours in Part 2.Baseline was calculated by 'pooling' samples from 6 sites adjacent to each timepoint. |
| 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. | Roll plate cultures (quantitative) measured CFU on catheter tips after removal up to 7 days after insertion. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | ITT set consists of all subjects who received at least one study treatment and had data available at 72 hours. | log 10 CFU/cm sq | MEAN |
| 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. | In Part 2 of the study 25 subjects had only omiganan applied to sites across the upper chest or abdomen.Swab cultures were obtained over a period of 7 days at protocol-specified times | log 10 CFU/sq. cm | MEAN |
| 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. | intravenous (IV) catheters were removed for culture from 5 subjects at 72 hours, 10 subjects at 5 days, and 10 subjects at 7 days. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours | Omiganan 1% Gel (Part 2) | -1.91 | Standard Deviation 1.563 | log 10 CFU/cm sq | |
| Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours | Chlorhexidine 2%(Part 1) | -1.87 | Standard Deviation 1.656 | log 10 CFU/cm sq | |
| Change in Mean Number of Skin Bacterial Counts From Baseline to 7 Days | Omiganan 1% Gel (Part 2) | -1.44 | Standard Deviation 1.511 | log 10 CFU/sq. cm | |
| Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs) | Omiganan 1% Gel (Part 2) | 0 | participants | ||
| Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs) | Chlorhexidine 2%/ Isopropyl Alcohol | 1 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 | STARTED | Omiganan 1% Gel and Chlorhexidine | 25 | |
| Part 1 | COMPLETED | Omiganan 1% Gel and Chlorhexidine | 24 | |
| Part 1 | NOT COMPLETED | Omiganan 1% Gel and Chlorhexidine | 1 | |
| Part 2 | STARTED | Omiganan 1% Gel and Chlorhexidine | 25 | |
| Part 2 | COMPLETED | Omiganan 1% Gel and Chlorhexidine | 25 | |
| Part 2 | NOT COMPLETED | Omiganan 1% Gel and Chlorhexidine | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Omiganan 1% Gel (Part 1) | 0 | 25 | 0 |
| other | Headache | Nervous system disorders | Chlorhexidine | 2 | 25 | 2 |
| other | Headache | Nervous system disorders | Omiganan 1% (Part 2) | 2 | 25 | 2 |
| other | Catheter Site Pain | General disorders | Omiganan 1% Gel (Part 1) | 0 | 0 | 0 |
| other | Catheter Site Pain | General disorders | Chlorhexidine | 7 | 25 | 7 |
| other | Catheter Site Pain | General disorders | Omiganan 1% (Part 2) | 7 | 25 | 7 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omiganan 1% Gel (Part 1) | ||
| Total, all-cause mortality | Chlorhexidine | ||
| Total, all-cause mortality | Omiganan 1% (Part 2) | ||
| Total, other adverse events | Omiganan 1% Gel (Part 1) | 0 | 25 |
| Total, other adverse events | Chlorhexidine | 7 | 25 |
| Total, other adverse events | Omiganan 1% (Part 2) | 8 | 25 |
| Total, serious adverse events | Omiganan 1% Gel (Part 1) | 0 | 25 |
| Total, serious adverse events | Chlorhexidine | 0 | 25 |
| Total, serious adverse events | Omiganan 1% (Part 2) | 0 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Omiganan 1% Gel (Part 2) vs Chlorhexidine 2%/ Isopropyl Alcohol: Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00608959
GET https://conductscience.org/api/trials/v1/NCT00608959/registered