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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nail Polish + Efinaconazole Solution | Active Comparator | One big toe will receive application of Efinaconazole Solution on top of nail polish (without the presence of a top coat or base coat) |
|
| Nail Polish Only | Placebo Comparator | Both big toes will use nail polish only |
|
| Base Coat + Nail Polish + Top Coat + Efinaconazole Solution | Active Comparator | 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 | Active Comparator | One big toe will receive application of Efinaconazole solution on top of nail polish with top coat. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nail Polish + Efinaconazole Solution | Drug | Application of Jublia to the nail of one big toe on top of the nail polish |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirklin Clinic | Birmingham | Alabama | 35249 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Efinaconazole Solution and Nail Polish | Efinaconazole Solution and Nail Polish only (no base coat and no top coat) applied to great toenail |
| FG001 | Nail Polish Only | No efinaconazole applied to one great toe. Only Nail per treatment arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2016 |
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| Nail polish | Other | Application of nail polish only to both big toe nails |
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| Base Coat + Nail Polish + Top Coat + Efinaconazole Solution | Drug | Application of Jublia to the nail of one big toe on top of the nail polish with layers of top coat and base coat |
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| Nail Polish + Top Coat + Efinaconazole Solution | Drug | Application of Jublia to the nail of one big toe on top of the nail polish with layer of top coat |
|
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| FG002 | 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. |
| FG003 | Nail Polish + Top Coat + Efinaconazole Solution | One big toe will receive application of Efinaconazole solution on top of nail polish with top coat. |
| Nail Polish |
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| Nail Polish, Base Coat |
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| Nail Polish, Top Coat |
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| COMPLETED |
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| NOT COMPLETED |
|
Healthy adult with large toenail present
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| ID | Title | Description |
|---|---|---|
| BG000 | Jublia | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | Posted | Median | Standard Deviation | days of stability | Baseline to 14 days | nail polish cycle | nail polish cycle |
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50 nail application cycles, 14 days of jublia application.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Jublia | Both big toes will receive application of nail polish. . Only one big toe will use efinaconazole. Jublia: Application of Jublia to one big toes Nail polish: Application of nail polish to both big toe nails Subjects had to be healthy and have a big toenail | 0 | 5 | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials, UAB Dermatology | UAB | 2055029960 | Lmroop@uabmc.edu |
| Dec 17, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C431707 | efinaconazole |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| nail polish cycle |
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