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This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal infections in patients who wear polish compared to those who do not.
Topical efinaconazole 10% solution is known to be an efficacious and safe treatment modality for toenail onychomycosis. This study will examine the compatibility of topical efinaconazole and nail polish in patients with distal and lateral subungual onychomycosis (DLSO). It is hypothesized that the treatment of DLSO with efinaconazole 10% solution will not be adversely affected by the application of nail polish.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efinaconazole 10 % and Nail Polish | Active Comparator | Subject will have Efinaconazole 10% solution application and nail polish |
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| Efinaconazole 10% without Nail Polish | Placebo Comparator | Subject will have only Efinaconazole 10% application and no nail polish |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efinaconazole 10% Topical Application Solution [JUBLIA] | Drug | Topical efinaconazole 10% solution (Jublia) |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Nail Polish Disruption Using the Likert Scale | Patients will answer the following question: Which will be answered using a Likert scale where 0 represents no alteration in polish and 10 represents complete destruction of the polish: Is the quality of your polish diminished with use of Jublia? | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI) | Using 3rd party blinding, DLSO was assessed at baseline and at every subsequent visit using the onychomycosis severity index (OSI), measuring percent of the target nail involved, and grading the infection from mild to moderate to severe. The range for OSI is 0-20 with 20 indicating severe nails disease. Nail growth was measured at each visit. Fungal testing was done at screening, 3 months, 7 months, end of treatment (48 weeks), and end of study (52 weeks). Clinical and mycologic cure was evaluated at week 52. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boni E Elewski, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirklin Clinic | Birmingham | Alabama | 35249 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group (Frequently Wears Toenail Polish) | Patients who self-identified as frequently wearing toenail polish were placed in the study group. Inclusion criteria consisted of being female and aged 19-70 with distal and lateral subungual onychomycosis (DLSO) effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing. Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks. |
| 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 | Jan 14, 2019 |
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| Application of Nail Polish | Other | Application of Nail Polish |
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| 52 week |
| FG001 | Control Group (no Toenail Polish) | The control group was comprised of women who agreed to abstain from wearing toenail polish throughout the length of the study. Inclusion criteria consisted of being female and aged 19-70 with DLSO effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing. Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Wearing Toenail Polish | Subject will have Efinaconazole 10% application and nail polish Efinaconazole 10% (Jublia): Topical Efinaconazole 10% solution Application of nail polish |
| BG001 | Abstain From Wearing Toenail Polish | Subject will have Efinaconazole 10% application and no nail polish Efinaconazole 10% (Jublia): Topical Efinaconazole 10% solution |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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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 | Percentage of Nail Polish Disruption Using the Likert Scale | Patients will answer the following question: Which will be answered using a Likert scale where 0 represents no alteration in polish and 10 represents complete destruction of the polish: Is the quality of your polish diminished with use of Jublia? | Only participants who completed the trial were included in results. Two participants withdrew due to personal scheduling conflicts. | Posted | Mean | Full Range | percentage of nail polish disruption | 52 weeks |
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| Secondary | Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI) | Using 3rd party blinding, DLSO was assessed at baseline and at every subsequent visit using the onychomycosis severity index (OSI), measuring percent of the target nail involved, and grading the infection from mild to moderate to severe. The range for OSI is 0-20 with 20 indicating severe nails disease. Nail growth was measured at each visit. Fungal testing was done at screening, 3 months, 7 months, end of treatment (48 weeks), and end of study (52 weeks). Clinical and mycologic cure was evaluated at week 52. | We did not include results from the two participants who withdrew from the study due to personal scheduling conflicts. Results for only 11 subjects who completed the study are represented in the number of participants analyzed. | Posted | Mean | Full Range | percentage change target nail | 52 week |
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52 Weeks
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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 | Efinaconazole 10% and Nail Polish | Patients who self-identified as frequently wearing toenail polish were placed in the study group. Inclusion criteria consisted of being female and aged 19-70 with DLSO effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing. Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG001 | Efinaconazole 10% Without Nail Polish | The control group was comprised of women who agreed to abstain from wearing toenail polish throughout the length of the study. Inclusion criteria consisted of being female and aged 19-70 with DLSO effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing. Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks. | 0 | 6 | 0 | 6 | 0 | 6 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Roop | UAB | 2059754917 | lmroop@uabmc.edu |
| Feb 27, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C431707 | efinaconazole |
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| Asian |
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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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| Units | Counts |
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