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NCT03405818 · ClinicalTrials.gov registry record · Phase 4
An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 55
- Enrollment target
NCT03405818 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 55 participants.
The verdict
NCT03405818, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 55 participants
- Enrollment target
Study Summary
This was an open-label study to evaluate the safety and pharmacokinetics of tavaborole 5% topical solution in treating distal subungual onychomycosis (a fungal infection) of the toenail in children and adolescents (ages 6 to 16 years). Following confirmation of eligibility, including laboratory evidence of a fungal organism in the toenail, tavaborole topical solution was applied once daily to all affected toenails for a 48-week treatment period. Clinical assessment of the extent of infection and safety assessments were performed periodically throughout the 48-week treatment period, and again at 52 weeks (4 weeks after stopping the treatment). A subgroup of enrolled subjects applied the topical solution to all 10 toenails and a small area of surrounding skin during the first 28 days. These subjects had blood samples analyzed to evaluate the pharmacokinetics (how the drug moves in the body) of tavaborole topical solution in children and adolescents.
Interventions
- DRUG Tavaborole 5% Topical Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2015-10-22 |
| Est. Completion | 2017-07-27 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03405818
The ClinicalTrials.gov registry entry for NCT03405818 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tavaborole 5% Topical Solution is the first listed.
NCT03405818 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03405818 about?
NCT03405818 is a clinical study titled "An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents". This was an open-label study to evaluate the safety and pharmacokinetics of tavaborole 5% topical solution in treating distal subungual onychomycosis (a fungal infection) of the toenail in children and adolescents (ages 6 to 16 years). Following confirmation of eligibility, including laboratory evi...
What is the current status of trial NCT03405818?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 55 participants. The study started on 2015-10-22. Estimated completion is 2017-07-27.
What interventions are being tested in trial NCT03405818?
The interventions under investigation include: Tavaborole 5% Topical Solution (DRUG).
Who is sponsoring clinical trial NCT03405818?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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