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

• ClinicalTrials.gov Identifier: NCT02812771
• Recruitment Status: Completed
• First Posted: June 24, 2016
• Last Update Posted: November 22, 2019
• Sponsor: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Onychomycosis	Drug: Efinaconazole	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: August 4, 2016
• Actual Primary Completion Date: January 14, 2019
• Actual Study Completion Date: January 14, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Efinaconazole; Efinaconazole	Drug: Efinaconazole; Solution

Outcome Measures

Primary Outcome Measures :

1. Adverse Events will be collected as spontaneous reports by the subjects and as observations by the investigators. . [ Time Frame: 48 weeks ]
   Measurements will be taken as; Local Skin Reactions (redness, swelling, burning, itching, and vesiculation) on a 4-point scale from none to severe. Blood and Urine samples will be collected for routine clinical laboratory tests (hematology, serum chemistry, and urinanalysis). And lastly vital sign measurements (blood pressure, respiration, pulse, and temperature.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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).

Contacts and Locations

Locations

United States, Alabama

Valeant Site 01

Birmingham, Alabama, United States, 35201

United States, California

Valeant Site 04

Fountain Valley, California, United States, 92708

Valeant Site 03

Santa Rosa, California, United States, 95403

United States, Florida

Valeant SIte 05

South Miami, Florida, United States, 33143

United States, Louisiana

Valeant Site 09

New Orleans, Louisiana, United States, 70130

United States, Maryland

Valeant Site 08

Baltimore, Maryland, United States, 21214

United States, New York

Valeant Site 02

Forest Hills, New York, United States, 11375

United States, Pennsylvania

Valeant Site 06

Philadelphia, Pennsylvania, United States, 19107

United States, Texas

Valeant Site 07

McAllen, Texas, United States, 78501

Dominican Republic

Valeant Site 10

Santo Domingo, Dominican Republic

Sponsors and Collaborators

Bausch Health Americas, Inc.

Investigators

• Study Director: Binu Alexander, MD; Valeant Pharmaceuticals

More Information

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT02812771
• Other Study ID Numbers: V01-108A-401
• First Posted: June 24, 2016
• Last Update Posted: November 22, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Additional relevant MeSH terms:

Onychomycosis; Tinea; Dermatomycoses; Skin Diseases, Infectious; Infection; Mycoses; Nail Diseases; Skin Diseases; Efinaconazole; Antifungal Agents; Anti-Infective Agents