Clinical trial NCT02812771: Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Onychomycosis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-24
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Percentage of Participants With at Least One Adverse Event
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Valeant Site 01
state: Alabama
city: Fountain Valley
country: United States
facility: Valeant Site 04
state: California
city: Santa Rosa
country: United States
facility: Valeant Site 03
state: California
city: South Miami
country: United States
facility: Valeant SIte 05
state: Florida
city: New Orleans
country: United States
facility: Valeant Site 09
state: Louisiana
city: Baltimore
country: United States
facility: Valeant Site 08
state: Maryland
city: Forest Hills
country: United States
facility: Valeant Site 02
state: New York
city: Philadelphia
country: United States
facility: Valeant Site 06
state: Pennsylvania
city: McAllen
country: United States
facility: Valeant Site 07
state: Texas
city: Santo Domingo
country: Dominican Republic
facility: Valeant Site 10
Study officials:
affiliation: Valeant Pharmaceuticals
name: Binu Alexander, MD
role: STUDY_DIRECTOR
References: