An interventional study of Nail Polish + Efinaconazole Solution and Nail polish in Evaluation of Jublia on Nail Polish With Healthy Toenails, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-06.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other
A recent publication using cadaver nails suggests that Jublia application has a negative effect on nail polish texture.
It is believed that investigating the affect of Jublia is an important question with regards to how it affects how various nail polished and top coats will be used.
University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One big toe will receive application of Efinaconazole Solution on top of nail polish (without the presence of a top coat or base coat)
Drug: Nail Polish + Efinaconazole Solution
Both big toes will use nail polish only
Other: Nail polish
One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.
Drug: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution
One big toe will receive application of Efinaconazole solution on top of nail polish with top coat.
Drug: Nail Polish + Top Coat + Efinaconazole Solution
Application of Jublia to the nail of one big toe on top of the nail polish
Also known as: Jublia
Application of nail polish only to both big toe nails
Application of Jublia to the nail of one big toe on top of the nail polish with layers of top coat and base coat
Also known as: Jublia
Application of Jublia to the nail of one big toe on top of the nail polish with layer of top coat
Also known as: Jublia
Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days
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)
Time frame: Baseline to 14 days
| Milestone | Efinaconazole Solution and Nail Polish | Nail Polish Only | Efinaconazole Solution, Nail Polish, Top Coat, and Base Coat | Nail Polish + Top Coat + Efinaconazole Solution |
|---|---|---|---|---|
| Started | 5 | 5 | 5 | 5 |
| Nail polish | 5 | 5 | 5 | 5 |
| Nail polish, base coat | 5 | 5 | 5 | 5 |
| Nail polish, top coat | 5 | 5 | 5 | 5 |
| Completed | 5 | 5 | 5 | 5 |
| Not completed | 0 | 0 | 0 | 0 |
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)
| days of stability | Nail Polish and Efinaconazole Solution | Efinaconazole Solution, Nail Polish, and Top Coat | Placebo Comparator: Nail Polish Only | Base Coat + Nail Polish + Top Coat + Efinaconazole Solution |
|---|---|---|---|---|
| Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days | 1.5 ± 0.5 | 5 ± 2 | 15 ± 0 | 5 ± 2 |
Collected over 50 nail application cycles, 14 days of jublia application.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Jublia | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
Healthy adult with large toenail present
| Age, Categorical(Participants) | Jublia |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Jublia |
|---|---|
| Female | 5 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Jublia |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 5 |
| Region of Enrollment(Participants) | Jublia |
|---|---|
| United States | 5 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alabama at Birmingham