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An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents

Last updated on November 29, 2019

FOR MORE INFORMATION
Study Location
Madera Family Medical Group
Madera, California, 93637 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Onychomycosis, Tinea Unguium
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
72-203 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT03405818
Pfizer
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

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Descriptive Information
Brief Title  ICMJE An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
Official Title  ICMJE 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

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.

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 subjects aged 6 to 16 years and 11 months. An eligible subject had a target great toenail (TGT) with at least 20% involvement, with a positive potassium hydroxide (KOH) wet mount and positive fungal culture for T. rubrum or T. mentagrophytes.

Eligible subjects applied tavaborole 5% topical solution, once daily to all affected toenails (the TGT as well as all other toenails having the clinical characteristics of onychomycosis) throughout the 48 week treatment period.

Subjects were evaluated at Screening, Baseline (Day 1), and at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 52. Each evaluation included a clinical assessment of the AEs and local tolerability evaluation.

Additional procedures were performed as follows:

  • Mycology sampling at Screening, Week 24, and Week 52/early termination (ET);
  • Clinical disease severity of the TGT at Screening, Week 24, and Week 52/ET;
  • Safety laboratory testing at Baseline, Week 24, and Week 52/ET;

In this study, there was a PK subgroup of evaluable subjects aged 12 to 16 years and 11 months studied under maximal use conditions. Subjects in this maximal use subgroup applied the study drug on all 10 toenails, including up to 2 mm of the surrounding skin, for 28 days. On Day 15, a predose PK sample was collected to assess steady state trough level. On Day 29, the study drug application was done at the study site, and PK samples were collected prior to dosing, as well as 4, 6, 8, and 24 hours postdose on Days 29 to 30.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
This was a single group study.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition  ICMJE
  • Onychomycosis
  • Tinea Unguium
Intervention  ICMJE Drug: Tavaborole 5% Topical Solution
topical solution for application to toenails
Other Name: Kerydin
Study Arms  ICMJE Experimental: Tavaborole 5% Topical Solution
All study participants apply study drug
Intervention: Drug: Tavaborole 5% Topical Solution
Publications *Rich P, Spellman M, Purohit V, Zang C, Crook TJ. Tavaborole 5% Topical Solution for the Treatment of Toenail Onychomycosis in Pediatric Patients: Results from a Phase 4 Open-Label Study. J Drugs Dermatol. 2019 Feb 1;18(2):190-195.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2018)
55
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 27, 2017
Actual Primary Completion DateJuly 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • males or females, ages >/= 6 years and
  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 72 Months to 203 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03405818
Other Study ID Numbers  ICMJE TAV-ONYC-401
C3371003 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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