Trial Outcomes & Findings for Real-World Evaluation of the Effect of Jublia on Nail Polish (NCT NCT03022916)

Last Updated: 2020-01-06

Results Overview

Observation: Serial photographs were combined with patient reported outcomes to assess the stability of self-applied toenail polish when efinaconazole was applied topically to the nail. (Expected stability of polish less than 14 days with application of Jublia as compared to nails without Jublia application)

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

Baseline to 14 days

Results posted on

2020-01-06

Participant Flow

Each patient served as their own control. One big toenail received nail polish only and the other big toenail was treated with nail polish and efinaconazole solution.

Unit of analysis: great toenail

Participant milestones

Participant milestones
Measure	Efinaconazole Solution and Nail Polish Efinaconazole Solution and Nail Polish only (no base coat and no top coat) applied to great toenail	Nail Polish Only No efinaconazole applied to one great toe. Only Nail per treatment arm	Efinaconazole Solution, Nail Polish, Top Coat, and Base Coat One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.	Nail Polish + Top Coat + Efinaconazole Solution One big toe will receive application of Efinaconazole solution on top of nail polish with top coat.
Overall Study STARTED	5 5	5 5	5 5	5 5
Overall Study Nail Polish	5 5	5 5	5 5	5 5
Overall Study Nail Polish, Base Coat	5 5	5 5	5 5	5 5
Overall Study Nail Polish, Top Coat	5 5	5 5	5 5	5 5
Overall Study COMPLETED	5 5	5 5	5 5	5 5
Overall Study NOT COMPLETED	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Real-World Evaluation of the Effect of Jublia on Nail Polish

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Jublia n=5 Participants Both big toes will receive application of toenail polish. One big toe will not use Jublia. Jublia: Application of Jublia to one big toenail Nail polish: Application of nail polish to both big toe nails Subjects had to be healthy and have a big toenail
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 14 days

Population: Healthy adults with normal appearing big toenails applied toenail polish to both big toes. Jublia was applied to one big toe daily on top of the nail polish. Serial photography and participant report demonstrated the day until the nail polish degraded (became damaged). Control results were not analyzed.

Outcome measures

Outcome measures
Measure	Nail Polish and Efinaconazole Solution n=15 nail polish cycle Nail polish and Efinaconazole solution application (daily application of Efinaconazole solution)	Efinaconazole Solution, Nail Polish, and Top Coat n=15 nail polish cycle Efinaconazole solution applied daily to nail with top coat and nail polish	Placebo Comparator: Nail Polish Only n=15 nail polish cycle Both big toes will use nail polish only	Base Coat + Nail Polish + Top Coat + Efinaconazole Solution n=15 nail polish cycle Active Comparator: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.
Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days	1.5 days of stability Standard Deviation 0.5	5 days of stability Standard Deviation 2	15 days of stability Standard Deviation 0	5 days of stability Standard Deviation 2

Adverse Events

Jublia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials, UAB Dermatology

UAB

Phone: 2055029960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place