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

A Multicenter, Open Label, Single-arm Study Evaluating the Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis of the Toenails

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.

Study Overview

• Status: Completed
• Conditions: Onychomycosis
• Intervention / Treatment: Drug: Efinaconazole

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Valeant Site 10
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35201
      • Valeant Site 01
  • California
    • Fountain Valley, California, United States, 92708
      • Valeant Site 04
    • Santa Rosa, California, United States, 95403
      • Valeant Site 03
  • Florida
    • South Miami, Florida, United States, 33143
      • Valeant Site 05
  • Louisiana
    • New Orleans, Louisiana, United States, 70130
      • Valeant Site 09
  • Maryland
    • Baltimore, Maryland, United States, 21214
      • Valeant Site 08
  • New York
    • Forest Hills, New York, United States, 11375
      • Valeant Site 02
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Valeant Site 06
  • Texas
    • McAllen, Texas, United States, 78501
      • Valeant Site 07

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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).

Key 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Efinaconazole	Drug: Efinaconazole; Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With at Least One Adverse Event	48 weeks

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Binu Alexander, MD, Valeant Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2016
• Primary Completion (Actual): January 14, 2019
• Study Completion (Actual): January 14, 2019

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis; Anti-Infective Agents; Antifungal Agents; Efinaconazole
• Other Study ID Numbers: V01-108A-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No