An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
Public ClinicalTrials.gov record NCT03405818. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Kerydin (Registered) (Tavaborole) Topical Solution, 5% In The Treatment Of Onychomycosis Of The Toenail In Pediatric Subjects Ages 6 To 16 Years And 11 Months
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03405818
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 55 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 72 Months to 203 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 21, 2015
- Primary completion
- Jul 26, 2017
- Completion
- Jul 26, 2017
- Last update posted
- Apr 16, 2018
2015 – 2017
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Madera Family Medical Group | Madera | California | 93637 | — |
| Stanford University School of Medicine | Palo Alto | California | 94304 | — |
| MedStar Health Research Institute - MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Doctors Research Network | South Miami | Florida | 33143 | — |
| University Hospital, SUNY Downstate Medical Center | Brooklyn | New York | 11203 | — |
| Skin Specialty Dermatology | New York | New York | 10155 | — |
| Cyn3rgy Research | Gresham | Oregon | 97030 | — |
| Oregon Dermatology & Research Center | Portland | Oregon | 97210 | — |
| West Houston Clinical Research Services LLC | Houston | Texas | 77055 | — |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | — |
| Jordan Valley Dermatology Center | West Jordan | Utah | 84088 | — |
| PI Coor Clinical Research, LLC | Burke | Virginia | 22015 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03405818, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 16, 2018 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03405818 live on ClinicalTrials.gov.