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

Phase 4

Completed

• Conditions: Onychomycosis
• Interventions: Drug: Efinaconazole

• Registration Number: NCT02812771
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Study Timeline

• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-24
• Study Start: 2016-08-04
• Primary Completion: 2019-01-14
• Study Completion: 2019-01-14
• Disposition First Submitted: 2019-11-12
• Disposition First Submitted QC: 2019-11-12
• Disposition First Posted: 2019-11-19
• Status Verified: 2021-10
• Results First Submitted: 2021-10-01
• Results First Submitted QC: 2021-10-01
• Last Update Submitted: 2021-10-01
• Results First Posted: 2021-11-01
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Efinaconazole	Efinaconazole	Efinaconazole

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least One Adverse Event	48 weeks

Trial Locations

Locations (10)

Valeant Site 01; 🇺🇸 Birmingham, Alabama, United States

Valeant Site 08; 🇺🇸 Baltimore, Maryland, United States

Valeant Site 06; 🇺🇸 Philadelphia, Pennsylvania, United States

Valeant Site 03; 🇺🇸 Santa Rosa, California, United States

Valeant Site 04; 🇺🇸 Fountain Valley, California, United States

Valeant SIte 05; 🇺🇸 South Miami, Florida, United States

Valeant Site 09; 🇺🇸 New Orleans, Louisiana, United States

Valeant Site 02; 🇺🇸 Forest Hills, New York, United States

Valeant Site 07; 🇺🇸 McAllen, Texas, United States

Valeant Site 10; 🇩🇴 Santo Domingo, Dominican Republic