An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
Completed · Phase 4
Conditions studied: Onychomycosis, Tinea Unguium
In brief
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.
Key facts
- Study ID
- NCT03405818
- Run by
- Pfizer
- People needed
- 55
- Starts
- 2015-10-22
- Expected to finish
- 2017-07-27
- Last updated by the study team
- 2018-04-17
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- males or females, ages >/= 6 years and </= 16 years and 11 months
- clinical diagnosis of distal subungual onychomycosis affecting at least 20% of one of the great toenails (target nail); and with positive KOH and positive culture for T. rubrum or T. mentagrophytes from either great toenail
You may not qualify if…
- the target toenail has proximal subungual onychomycosis, onychomycosis involving the nail lunula, superficial white onychomycosis, dermatophytoma, exclusively lateral disease, or yellow or brown spikes, or has co-infection with certain fungi or molds
- anatomic abnormalities of the toes or toenail
- current or past history of chronic moccasin-type tinea pedis
- current or past history of psoriasis or lichen planus
- history of significant chronic fungal disease (other than onychomycosis)
- diabetes
- immunodeficiency
Where it is running
- Madera Family Medical Group — Madera, California, United States
- Stanford University School of Medicine — Palo Alto, California, United States
- MedStar Health Research Institute - MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
- Doctors Research Network — South Miami, Florida, United States
- University Hospital, SUNY Downstate Medical Center — Brooklyn, New York, United States
- Skin Specialty Dermatology — New York, New York, United States
- Cyn3rgy Research — Gresham, Oregon, United States
- Oregon Dermatology & Research Center — Portland, Oregon, United States
- West Houston Clinical Research Services LLC — Houston, Texas, United States
- Texas Dermatology and Laser Specialists — San Antonio, Texas, United States
- Jordan Valley Dermatology Center — West Jordan, Utah, United States
- PI Coor Clinical Research, LLC — Burke, Virginia, United States
Full record on ClinicalTrials.gov
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