Trial Outcomes & Findings for Topical Antimicrobial Effectiveness Testing (NCT NCT01366417)
NCT ID: NCT01366417
Last Updated: 2025-12-11
Results Overview
Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 30 seconds after a single application of test material relative to the baseline bacterial count.
COMPLETED
PHASE4
25 participants
30 seconds after treatment
2025-12-11
Participant Flow
First subject/first visit: May 12, 2011 Last subject/last visit: June 8, 2011
43 subjects entered screening phase.25 subjects had qualifying treatment day baseline counts and completed the study.
Participant milestones
| Measure |
ChloraPrep One Step and 70% Isopropyl Alcohol
All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
Signed Informed Consent
|
43
|
|
Overall Study
Completed Screen Visit
|
33
|
|
Overall Study
Completed Treatment Visit
|
28
|
|
Overall Study
Completed the Study
|
28
|
|
Overall Study
Discontinued Prior to Treatment
|
5
|
|
Overall Study
Excluded From Analysis
|
3
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Antimicrobial Effectiveness Testing
Baseline characteristics by cohort
| Measure |
ChloraPrep One Step and 70% Isopropyl Alcohol
n=28 Participants
All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=237 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=237 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=237 Participants
|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 16.71105 • n=237 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=237 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=237 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=237 Participants
|
PRIMARY outcome
Timeframe: 30 seconds after treatmentPopulation: subjects whose treatment day baseline microbial count met the qualification criteria and completed all assessments.
Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 30 seconds after a single application of test material relative to the baseline bacterial count.
Outcome measures
| Measure |
ChloraPrep One Step
n=25 Participants
All subjects received a single topical application of ChloraPrep One Step.
|
70% Isopropyl Alcohol
n=25 Participants
All subjects received a single topical application of 70% Isopropyl Alcohol.
|
|---|---|---|
|
Antimicrobial Efficacy
|
2.21 log 10 colony forming units / cm^2
95% Confidence Interval 0.1332 • Interval 1.95 to 2.48
|
2.25 log 10 colony forming units / cm^2
95% Confidence Interval 0.1332 • Interval 1.99 to 2.51
|
PRIMARY outcome
Timeframe: 10 minutes after treatmentPopulation: Subjects whose Treatment Day Baseline bacterial counts met qualification criteria
Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 10 minutes after a single application of test material relative to the baseline bacterial count.
Outcome measures
| Measure |
ChloraPrep One Step
n=25 Participants
All subjects received a single topical application of ChloraPrep One Step.
|
70% Isopropyl Alcohol
n=25 Participants
All subjects received a single topical application of 70% Isopropyl Alcohol.
|
|---|---|---|
|
Antimicrobial Efficacy
|
2.65 log 10 colony forming units / cm^2
Interval 2.39 to 2.92
|
2.60 log 10 colony forming units / cm^2
Interval 2.33 to 2.86
|
Adverse Events
ChloraPrep One Step and 70% Isopropyl Alcohol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place