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NCT02633813 · ClinicalTrials.gov registry record · Phase 3
BE Study of Naftifine HCL
A Phase 3 study of Tinea Pedis, sponsored by Genzum Life Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 693
- Enrollment target
- 14
- Study locations
NCT02633813: Completed Phase 3 study of Tinea Pedis, sponsored by Genzum Life Sciences.
NCT02633813 is a Phase 3 study of Tinea Pedis that has completed, run by Genzum Life Sciences. The registered enrollment target is 693 participants, above the 250-participant average among 9 other Tinea Pedis trials with a reported enrollment target (177% higher). The trial reports 14 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02633813, a Phase 3 study of Tinea Pedis, has completed, sponsored by Genzum Life Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 693 participants
- Enrollment target
- 14
- Study locations
Study Summary
The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study. The study duration for each patient was 6 weeks: Following were the visit details. V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).
Primary Outcome
After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum. Absence of growth suggests complete cure.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Naftifine hydrochloride 2%
- DRUG Naftin® 2% (Naftifine hydrochloride 2%)
Study Locations (14)
Florida
- Moore Clinical Research Inc - Brandon
- Savin Medical Group Research - Miami
- International Dermatology Research, Inc, - Miami
- FXM Research Corp - Miami
- FXM Research Miramar - Miramar
- South Tampa, MOORE Clinical Research, Inc. - Tampa
- North Tampa MOORE Clinical Research, Inc. - Tampa
Texas
- Bellaire Dermatology Associates - Bellaire
- Research Across America - Dallas
- Family Practise - Mesquite
- Research Across America - Plano
Missouri
- Medi Search - Saint Joseph
San Cristóbal
- Instituto Dermatológico y Cirugía de Piel - Santo Domingo
Santo Domingo Province
- Instituto Dermatológico - Barrio Maria Auxiliadora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 693 participants |
| Start Date | 2015-03 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
What the finished NCT02633813 record still lists
NCT02633813 is an interventional study that assigns participants to a tested intervention. The registered 693 participants enrollment target is mid-sized for trials with a published cap, above the 250-participant average among 9 other Tinea Pedis trials with a reported enrollment target (177% higher).
The record links to 1 condition, with Tinea Pedis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02633813 lists 14 locations in 5 states (Florida, Texas, Missouri).
Frequently Asked Questions
What is clinical trial NCT02633813 about?
NCT02633813 is a clinical study titled "BE Study of Naftifine HCL". The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study. The study duration for each patient was 6 weeks: Following were the visit details. V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the ...
What is the current status of trial NCT02633813?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 693 participants. The study started on 2015-03. Estimated completion is 2015-12.
What conditions does trial NCT02633813 study?
This clinical trial studies the following conditions: Tinea Pedis.
What interventions are being tested in trial NCT02633813?
The interventions under investigation include: Placebo (DRUG), Naftifine hydrochloride 2% (DRUG), Naftin® 2% (Naftifine hydrochloride 2%) (DRUG).
Who is sponsoring clinical trial NCT02633813?
This trial is sponsored by Genzum Life Sciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02633813 being conducted?
This trial has 14 study locations across Florida, Missouri, Texas, San Cristóbal, Santo Domingo Province. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02633813's enrollment target sits among peer trials
693 1st of 9 higher than 9 of 9 other Tinea Pedis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tinea Pedis 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.
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