Status:
COMPLETED
An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
Lead Sponsor:
Pfizer
Conditions:
Onychomycosis
Tinea Unguium
Eligibility:
All Genders
72-203 years
Phase:
PHASE4
Brief 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 an...
Detailed Description
This was an open-label study to evaluate the safety, tolerability, and pharmacokinetics of tavaborole 5% topical solution in treating distal subungual onychomycosis (DSO) of the toenail in pediatric s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 22 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2017
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03405818
Start Date
October 22 2015
End Date
July 27 2017
Last Update
April 17 2018
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Madera Family Medical Group
Madera, California, United States, 93637
2
Stanford University School of Medicine
Palo Alto, California, United States, 94304
3
MedStar Health Research Institute - MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20016
4
Doctors Research Network
South Miami, Florida, United States, 33143