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NCT02160587 · ClinicalTrials.gov registry record · Phase 1
Safety Study to Evaluate the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA
A Phase 1 study, sponsored by Zurex Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 208
- Enrollment target
NCT02160587: Completed Phase 1 study, sponsored by Zurex Pharma.
NCT02160587 is a Phase 1 study that has completed, run by Zurex Pharma. The registered enrollment target is 208 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (247% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02160587, a Phase 1 study, has completed, sponsored by Zurex Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 208 participants
- Enrollment target
Study Summary
This is a safety study to determine the skin sensitization potential of ZuraPrep™ and ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of human subjects. Indications of both sensitization and skin irritation will be evaluated.
Primary Outcome
Only frank sensitization will be categorized, as a positive control (known sensitizing agent) is prohibitive due to ethical considerations/risk of life-time sensitization. Reactions observed will be assessed as to whether indicative of sensitization or of irritation.
Interventions
- DRUG 0.9% Physiological Saline
- OTHER ZuraPrep without IPA
- DRUG Chloraprep
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2014-07 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT02160587 record still lists
NCT02160587 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (247% higher).
The record links to 0 conditions, and to 3 interventions - of which 0.9% Physiological Saline is the first listed.
NCT02160587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02160587 about?
NCT02160587 is a clinical study titled "Safety Study to Evaluate the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA". This is a safety study to determine the skin sensitization potential of ZuraPrep™ and ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of human subjects. Indications of both sensitization and skin irritation will be evaluated.
What is the current status of trial NCT02160587?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 208 participants. The study started on 2014-07. Estimated completion is 2014-10.
What interventions are being tested in trial NCT02160587?
The interventions under investigation include: 0.9% Physiological Saline (DRUG), ZuraPrep without IPA (OTHER), Chloraprep (DRUG).
Who is sponsoring clinical trial NCT02160587?
This trial is sponsored by Zurex Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02160587's enrollment target sits among peer trials
208 250th of 2000 higher than 1,749 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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