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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: Completed Phase 4 study, sponsored by Pfizer.
NCT03405818 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 55 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Local tolerability reactions consisted of burning/stinging, induration/edema, oozing and crusting, pruritus, erythema, and scaling. Here 0 indicates None, 1 (Mild), 2 (Moderate) and 3 (severe). Grading details are as follows: Burning/Stinging (0: no stinging/burning, 1: slight warm, 2: definite warm, 3: hot); Induration/Edema (0: no elevation, 1: barely perceptible elevation, 2: clearly perceptible elevation but not extensive, 3: marked and extensive elevation); Oozing and Crusting (0: absent, 1
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 |
What the finished NCT03405818 record still lists
NCT03405818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Tavaborole 5% Topical Solution is the first listed.
NCT03405818 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03405818's enrollment target sits among peer trials
55 1218th of 2000 higher than 778 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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