Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis

NCT ID: NCT02812771

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-04
• Study Completion Date: 2019-01-14

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.

Detailed Description

This is an open label, single-arm study designed to evaluate the safety and PK of a once daily topical application of efinaconazole in the treatment of pediatric subjects with mild to severe onychomycosis of the toenails.

Conditions

Onychomycosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Efinaconazole

Efinaconazole

Group Type: EXPERIMENTAL

Efinaconazole

Intervention Type: DRUG

Solution

Interventions

Efinaconazole

Solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Binu Alexander, MD

Role: STUDY_DIRECTOR

Valeant Pharmaceuticals

Locations

Valeant Site 01

Birmingham, Alabama, United States

Valeant Site 04

Fountain Valley, California, United States

Valeant Site 03

Santa Rosa, California, United States

Valeant SIte 05

South Miami, Florida, United States

Valeant Site 09

New Orleans, Louisiana, United States

Valeant Site 08

Baltimore, Maryland, United States

Valeant Site 02

Forest Hills, New York, United States

Valeant Site 06

Philadelphia, Pennsylvania, United States

Valeant Site 07

McAllen, Texas, United States

Valeant Site 10

Santo Domingo, , Dominican Republic

Countries

United States; Dominican Republic

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

V01-108A-401

Identifier Type: -

Identifier Source: org_study_id