NCT02812771

Brief Summary

Safety and Pharmacokinetics (PK) of a once daily topical application of efinaconazole in the treatment of pediatric subjects with mild to severe onychomycosis of the toenails.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2016

Typical duration for phase_4

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 4, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2019

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

November 1, 2021

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

2.4 years

First QC Date

June 22, 2016

Results QC Date

October 1, 2021

Last Update Submit

October 1, 2021

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With at Least One Adverse Event

    48 weeks

Study Arms (1)

Efinaconazole

EXPERIMENTAL

Efinaconazole

Drug: Efinaconazole

Interventions

EfinaconazoleDRUG

Solution

Efinaconazole

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male or female subjects of any race, 6 to 16 years of age (inclusive). PK Subset: Male or female subjects of any race, 12 to 16 years of age (inclusive).
  • Verbal and written informed consent/assent obtained from the subject and/or their parent or legal guardian.
  • Good general health, as assessed by the investigator, based on the subject's medical history, physical examination, and safety laboratory tests.
  • Target great toenail for all subjects, and both great toenails for subjects in the PK subset, must have evidence of toenail growth, per subject's report that monthly clipping is needed.
  • Subjects and their parents/legal guardians are willing to comply with study instructions and return to the investigational center for all required visits (a visit schedule with the length of each visit will be provided to ensure that the subject can meet the requirements and have adequate transportation).

You may not qualify if:

  • Females who are pregnant, nursing an infant, or planning a pregnancy during the study period.
  • History of immunosuppression and/or clinical signs indicative of possible immunosuppression, as determined by the investigator, or known human immunodeficiency virus infection.
  • History of diabetes that is uncontrolled as determined by the investigator (diabetes that is controlled by diet or medication does not exclude a subject).
  • Presence of any toenail infection other than or in addition to dermatophytes, such as Scytalidium as determined by the investigator (candidal onychomycosis infection, concurrent with a positive dermatophyte culture, is acceptable).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Valeant Site 01

Birmingham, Alabama, 35201, United States

Location

Valeant Site 04

Fountain Valley, California, 92708, United States

Location

Valeant Site 03

Santa Rosa, California, 95403, United States

Location

Valeant SIte 05

South Miami, Florida, 33143, United States

Location

Valeant Site 09

New Orleans, Louisiana, 70130, United States

Location

Valeant Site 08

Baltimore, Maryland, 21214, United States

Location

Valeant Site 02

Forest Hills, New York, 11375, United States

Location

Valeant Site 06

Philadelphia, Pennsylvania, 19107, United States

Location

Valeant Site 07

McAllen, Texas, 78501, United States

Location

Valeant Site 10

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

efinaconazole

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Study Director
Organization
Bausch Health Americas, Inc
aloncaric@bauschhealth.com
510-259-5284

Study Officials

  • Binu Alexander, MD

    Valeant Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 24, 2016

Study Start

August 4, 2016

Primary Completion

January 14, 2019

Study Completion

January 14, 2019

Last Updated

November 1, 2021

Results First Posted

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

Locations

US(9)DO(1)