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

Onychomycosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812771
• Other study ID #: V01-108A-401
• Status: Completed
• Phase: Phase 4
• Start date: August 4, 2016
• Est. completion date: January 14, 2019

Study information

• Verified date: October 2021
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 14, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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).

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• Efinaconazole
Solution

Locations

Country	Name	City	State
Dominican Republic	Valeant Site 10	Santo Domingo
United States	Valeant Site 08	Baltimore	Maryland
United States	Valeant Site 01	Birmingham	Alabama
United States	Valeant Site 02	Forest Hills	New York
United States	Valeant Site 04	Fountain Valley	California
United States	Valeant Site 07	McAllen	Texas
United States	Valeant Site 09	New Orleans	Louisiana
United States	Valeant Site 06	Philadelphia	Pennsylvania
United States	Valeant Site 03	Santa Rosa	California
United States	Valeant SIte 05	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

United States,  Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With at Least One Adverse Event		48 weeks