Onychomycosis
Conditions
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.
Interventions
DRUGEfinaconazole
Solution
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
Yes
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With at Least One Adverse Event | 48 weeks |
Countries
Dominican Republic, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Efinaconazole Efinaconazole
Efinaconazole: Solution | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Efinaconazole |
|---|---|
| Age, Continuous | 13.4 years STANDARD_DEVIATION 2.29 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 53 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 40 Participants |
| Target Great Tonail Left | 32 Participants |
| Target Great Tonail Right | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 20 / 60 |
| serious Total, serious adverse events | 2 / 60 |
Outcome results
Primary
Percentage of Participants With at Least One Adverse Event
Time frame: 48 weeks
Population: All participants who received at least 1 confirmed dose of study drug (Safety Population).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Efinaconazole | Percentage of Participants With at Least One Adverse Event | 39 Participants |