Trial Outcomes & Findings for Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis (NCT NCT02812771)

Last Updated: 2021-11-01

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

62 participants

Primary outcome timeframe

48 weeks

Results posted on

2021-11-01

Participant milestones
Measure	Efinaconazole Efinaconazole Efinaconazole: Solution
Overall Study STARTED	62
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	12

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Efinaconazole n=60 Participants Efinaconazole Efinaconazole: Solution
Age, Continuous	13.4 years STANDARD_DEVIATION 2.29 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Target Great Tonail Left	32 Participants n=5 Participants
Target Great Tonail Right	28 Participants n=5 Participants

Timeframe: 48 weeks

Population: All participants who received at least 1 confirmed dose of study drug (Safety Population).

Outcome measures
Measure	Efinaconazole n=60 Participants Efinaconazole Efinaconazole: Solution
Percentage of Participants With at Least One Adverse Event	39 Participants

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events
Measure	Efinaconazole n=60 participants at risk Efinaconazole Efinaconazole: Solution
Infections and infestations Pneumonia	1.7% 1/60 • 48 weeks All participants who received at least 1 confirmed dose of study drug (Safety Population).
Injury, poisoning and procedural complications Ankle fracture	1.7% 1/60 • 48 weeks All participants who received at least 1 confirmed dose of study drug (Safety Population).

Other adverse events
Measure	Efinaconazole n=60 participants at risk Efinaconazole Efinaconazole: Solution
Gastrointestinal disorders Food poisoning	5.0% 3/60 • 48 weeks All participants who received at least 1 confirmed dose of study drug (Safety Population).
Infections and infestations Influenza	8.3% 5/60 • 48 weeks All participants who received at least 1 confirmed dose of study drug (Safety Population).
Injury, poisoning and procedural complications Contusion	6.7% 4/60 • 48 weeks All participants who received at least 1 confirmed dose of study drug (Safety Population).
Injury, poisoning and procedural complications Nail injury	6.7% 4/60 • 48 weeks All participants who received at least 1 confirmed dose of study drug (Safety Population).
Nervous system disorders Headache	10.0% 6/60 • 48 weeks All participants who received at least 1 confirmed dose of study drug (Safety Population).
Skin and subcutaneous tissue disorders Ingrowing nail	6.7% 4/60 • 48 weeks All participants who received at least 1 confirmed dose of study drug (Safety Population).
Infections and infestations Nasopharyngitis	30.0% 18/60 • 48 weeks All participants who received at least 1 confirmed dose of study drug (Safety Population).
Infections and infestations Tinea pedis	6.7% 4/60 • 48 weeks All participants who received at least 1 confirmed dose of study drug (Safety Population).

Bausch Health Americas, Inc

Phone: 510-259-5284

Principal investigator is a sponsor employee Please contact sponsor directly for details.
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