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NCT00626795 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
A Phase 2 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 773
- Enrollment target
NCT00626795: Completed Phase 2 study, sponsored by LEO Pharma.
NCT00626795 is a Phase 2 study that has completed, run by LEO Pharma. The registered enrollment target is 773 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (481% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00626795, a Phase 2 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 773 participants
- Enrollment target
Study Summary
An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.
Primary Outcome
At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator. Investigator's assessment of severity of infections (SIRS). * Exudates/pus * Crusting * Erythema * Oedema * Tissue Warmth * Itching * Pain Each sign/symptoms of infection was assessed by use of the following 4-point scale: * 0 = absent * 2 = mild * 4 = moderate * 6 = severe The scores were summed up to a total SIRS score. Clinical cure was eithe
Interventions
- DRUG TD1414 2% cream
- DRUG Bactroban® (mupirocin) 2% cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 773 participants |
| Start Date | 2008-02 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
What the finished NCT00626795 record still lists
NCT00626795 is an interventional study that assigns participants to a tested intervention. The registered 773 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (481% higher).
The record links to 0 conditions, and to 2 interventions - of which TD1414 2% cream is the first listed.
NCT00626795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00626795 about?
NCT00626795 is a clinical study titled "Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)". An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children ...
What is the current status of trial NCT00626795?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 773 participants. The study started on 2008-02. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00626795?
The interventions under investigation include: TD1414 2% cream (DRUG), Bactroban® (mupirocin) 2% cream (DRUG).
Who is sponsoring clinical trial NCT00626795?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00626795's enrollment target sits among peer trials
773 42nd of 2000 higher than 1,959 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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