Trial Outcomes & Findings for Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients (NCT NCT03168841)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

50 weeks

Results posted on

2020-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	40
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group, Receiving Medication n=40 Participants 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.
Age, Continuous	58.15 years STANDARD_DEVIATION 9.71 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	31 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · African-American	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	1 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Intervention Group, Receiving Medication n=36 Participants 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.
Primary Endpoint - Efficacy	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group, Receiving Medication n=36 Participants 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.
Secondary Endpoint - Efficacy	21 Participants

SECONDARY outcome

Timeframe: 50 weeks

The second secondary efficacy end point is clinical cure, defined as 0% clinical involvement of the target toenail.

Outcome measures

Outcome measures
Measure	Intervention Group, Receiving Medication n=40 Participants 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.
Secondary Endpoint - Efficacy	8 Participants

SECONDARY outcome

Timeframe: 50 weeks

The secondary safety endpoint is the occurrence of adverse events (type and frequency).

Outcome measures

Outcome measures
Measure	Intervention Group, Receiving Medication n=40 Participants 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.
Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency)	4 Participants

Adverse Events

Intervention Group, Receiving Medication

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention Group, Receiving Medication n=40 participants at risk 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.
Skin and subcutaneous tissue disorders Application site vesicles, local	5.0% 2/40 • Number of events 2 • 1 year

Additional Information

David Shofler

Western University of Health Sciences

Phone: 9097063898

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place