Trials / Completed
CompletedNCT02296645
Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™ (ZX-ZP-0055)
A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Zurex Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a randomized, paired-comparisons design where each subject receives two of the planned treatments.
Detailed description
ZuraPrep is being evaluated for safety and efficacy as a preoperative skin preparation against the Tentative Final Monograph (TFM) 10-minute end point recently revised by the FDA for the lower bound of a 95% confidence interval whereas there must be specific reductions of normal flora in the abdomen and groin areas. A positive control will be evaluated as well.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ZuraPrep | Apply topically. |
| DRUG | ChloraPrep | Apply topically. |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2014-11-20
- Last updated
- 2016-07-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02296645. Inclusion in this directory is not an endorsement.