Onychomycosis of Toenail
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGEfinaconazole 10% Topical Application Solution [JUBLIA]
Topical efinaconazole 10% solution (Jublia)
OTHERApplication of Nail Polish
Application of Nail Polish
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Female age 19-70, as 19 is the legal age in Alabama * DLSO affecting at least 1 great toenail diagnosed with positive potassium hydroxide microscopy and culture of a dermatophyte * Suitable for application of topical antifungal therapy, in the opinion of the investigator * Target toenail thickness of 3 mm or less as measured by digital caliper, as thickness greater than 3 mm may allow inclusion of patient with severe onychomycosis, and this was the criteria used in the pivotal trial using topical efinaconazole for onychomycosis * Women of childbearing potential will be required to use birth control and a negative urine pregnancy test must be documented prior to initiating treatment
Exclusion criteria
* History of immunosuppression or concurrent use of immunosuppressant drugs * History of uncontrolled diabetes mellitus * History of psoriasis or any other condition that might interfere with the toenail evaluation * Three or more dermatophytomas (streaks) on the target nail * Severe DLSO of the target nail * Patients who cannot refrain from wearing gel or plastic based polishes that are used in salons and that require curing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Nail Polish Disruption Using the Likert Scale | 52 weeks | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI) | 52 week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wearing Toenail Polish Subject will have Efinaconazole 10% application and nail polish
Efinaconazole 10% (Jublia): Topical Efinaconazole 10% solution
Application of nail polish | 7 |
| Abstain From Wearing Toenail Polish Subject will have Efinaconazole 10% application and no nail polish
Efinaconazole 10% (Jublia): Topical Efinaconazole 10% solution | 6 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Wearing Toenail Polish | Abstain From Wearing Toenail Polish | Total |
|---|---|---|---|
| Age, Customized 19-70 | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Asian | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Black or African American | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Unknown or Not Reported | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) White | NA Participants | NA Participants | NA Participants |
| Region of Enrollment United States | 7 Participants | 6 Participants | 13 Participants |
| Sex/Gender, Customized Female | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
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?
Time frame: 52 weeks
Population: Only participants who completed the trial were included in results. Two participants withdrew due to personal scheduling conflicts.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Wearing Toenail Polish | Percentage of Nail Polish Disruption Using the Likert Scale | 0.6 percentage of nail polish disruption |
| Abstain From Wearing Toenail Polish | Percentage of Nail Polish Disruption Using the Likert Scale | 0 percentage of nail polish disruption |
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.
Time frame: 52 week
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Wearing Toenail Polish | Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI) | 0.56 percentage change target nail |
| Abstain From Wearing Toenail Polish | Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI) | 0.54 percentage change target nail |