Onychomycosis
Conditions
Brief summary
Onychomycosis, a common pathology of the toenails, is even more prevalent among diabetic subjects. Nearly 26 million Americans suffer from diabetes, and approximately one-third of subjects with diabetes have toenail onychomycosis. Numerous studies have addressed the efficacy and safety of both topical and oral antifungal treatment options for onychomycosis in diabetic subjects. However, no study to date has specifically addressed the efficacy and safety of efinaconazole among diabetic subjects. The objective of this noncomparative, uncontrolled study is to determine the efficacy of topical efinaconazole 10% for toenail onychomycosis among subjects with diabetes mellitus. Specific indicators to measure efficacy of treatment will be the mycological cure rate, complete cure rate, and treatment success. Furthermore, an additional goal of the study is to gain knowledge of safety in the setting of a cohort of diabetic subjects
Interventions
DRUGEfinaconazole Topical
Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.
Sponsors
Western University of Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of onychomycosis confirmed through positive KOH stain or positive mycologic culture findings. * Involvement of at minimum 20% of the target great toenail.
Exclusion criteria
* Diagnosis of a nondermatophyte fungus infection, diagnosis of proximal subungual onychomycosis, diagnosis of superficial white onychomycosis * Diagnosis of peripheral arterial disease or anatomic abnormalities of the target toenail * Inability to follow through with all requisite office visits * Routine use of a systemic corticosteroid, routine use of a systemic immunomodulator, or history of systemic antifungals within the prior five years. * Active interdigital tinea pedis refractory to topical antifungal treatments * Known hypersensitivity to efinaconazole * Use, within the month preceding screening, of: topical antifungal agents, topical anti-inflammatory agents to the toes * Any history of oral systemic antifungal with known activity against dermatophytes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint - Efficacy | 50 weeks | The primary efficacy end point is the proportion of subjects achieving complete cure at week 50. Complete cure is to be defined as a combination of 0% clinical involvement and mycological cure (mycological cure defined as negative KOH examination and negative fungal culture of the target toenail sample). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint - Efficacy | 50 weeks | The first secondary efficacy end point is mycological cure, defined as negative KOH examination and negative fungal culture of the target toenail sample. |
| Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency) | 50 weeks | The secondary safety endpoint is the occurrence of adverse events (type and frequency). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group, Receiving Medication Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.
Efinaconazole Topical: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Intervention Group, Receiving Medication |
|---|---|
| Age, Continuous | 58.15 years STANDARD_DEVIATION 9.71 |
| Race/Ethnicity, Customized Race/Ethnicity African-American | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 31 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 4 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 2 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Primary Endpoint - Efficacy
The primary efficacy end point is the proportion of subjects achieving complete cure at week 50. Complete cure is to be defined as a combination of 0% clinical involvement and mycological cure (mycological cure defined as negative KOH examination and negative fungal culture of the target toenail sample).
Time frame: 50 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group, Receiving Medication | Primary Endpoint - Efficacy | 4 Participants |
Secondary
Secondary Endpoint - Efficacy
The first secondary efficacy end point is mycological cure, defined as negative KOH examination and negative fungal culture of the target toenail sample.
Time frame: 50 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group, Receiving Medication | Secondary Endpoint - Efficacy | 21 Participants |
Secondary
Secondary Endpoint - Efficacy
The second secondary efficacy end point is clinical cure, defined as 0% clinical involvement of the target toenail.
Time frame: 50 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group, Receiving Medication | Secondary Endpoint - Efficacy | 8 Participants |
Secondary
Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency)
The secondary safety endpoint is the occurrence of adverse events (type and frequency).
Time frame: 50 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group, Receiving Medication | Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency) | 4 Participants |