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NCT00758862 · ClinicalTrials.gov registry record · Phase 2
The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo
A Phase 2 study of Impetigo and Secondarily Infected Traumatic Lesions (SITL), sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00758862: Completed Phase 2 study of Impetigo and Secondarily Infected Traumatic Lesions (SITL), sponsored by LEO Pharma.
NCT00758862 is a Phase 2 study of Impetigo and Secondarily Infected Traumatic Lesions (SITL) that has completed, run by LEO Pharma. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00758862, a Phase 2 study of Impetigo and Secondarily Infected Traumatic Lesions (SITL), has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
A national, prospective single arm phase II study investigating the pharmacokinetics and safety of the 2% TD1414 cream when applied 3 times daily for 7 days to adult patients with impetigo or Secondarily Infected Traumatic Lesions (SITL). A total of 20 patients will be enrolled.
Primary Outcome
On Days 1 and 2(and possibly Day 3 depending on the time of first application on Day 1) a sample was taken for pharmacokinetic(PK) analysis at any time before first application on Day 1, and at 12±1, 18±1, 24±1 and 36±4 hours after first application. If the 36±4 hours sampling time fell on Day 3, then a second sample was also required on Day 3, but was to be obtained at 6pm or afterwards. On Days 3 to 6(and also Day 7 if the very last application fell on Day 8), one sample was taken on each day
Conditions Studied
Interventions
- DRUG 2% TD1414 Cream
Study Locations (1)
Texas
- J&S Studies, Inc. - College Station
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-02 |
| Phase | Phase 2 |
What the finished NCT00758862 record still lists
NCT00758862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Impetigo appearing as the primary indexed condition, and to 1 intervention - of which 2% TD1414 Cream is the first listed.
NCT00758862 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00758862 about?
NCT00758862 is a clinical study titled "The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo". A national, prospective single arm phase II study investigating the pharmacokinetics and safety of the 2% TD1414 cream when applied 3 times daily for 7 days to adult patients with impetigo or Secondarily Infected Traumatic Lesions (SITL). A total of 20 patients will be enrolled.
What is the current status of trial NCT00758862?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2008-12. Estimated completion is 2009-02.
What conditions does trial NCT00758862 study?
This clinical trial studies the following conditions: Impetigo, Secondarily Infected Traumatic Lesions (SITL).
What interventions are being tested in trial NCT00758862?
The interventions under investigation include: 2% TD1414 Cream (DRUG).
Who is sponsoring clinical trial NCT00758862?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00758862 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00758862's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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