Evaluation of Jublia on Nail Polish With Healthy Toenails
Conditions
Keywords
toenail polish, jublia
Brief summary
A recent publication using cadaver nails suggests that Jublia application has a negative effect on nail polish texture.
Detailed description
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.
Interventions
DRUGNail Polish + Efinaconazole Solution
Application of Jublia to the nail of one big toe on top of the nail polish
OTHERNail polish
Application of nail polish only to both big toe nails
DRUGBase Coat + Nail Polish + Top Coat + Efinaconazole Solution
Application of Jublia to the nail of one big toe on top of the nail polish with layers of top coat and base coat
DRUGNail Polish + Top Coat + Efinaconazole Solution
Application of Jublia to the nail of one big toe on top of the nail polish with layer of top coat
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Exhibit distal lateral subungual onychomycosis (DLSO) * Has the informed consent been signed and patient's questions answered. * Age ≥ 18 * Patient willing and able to participate for the full duration of the study * No onychomycosis * Greater than 4 weeks from prior major surgery for any indication * Willing to abstain from: * The application of other topical medications or cosmetic products to the toenail * Professional pedicures for the duration of the study. * Females of childbearing potential must: * Have been using adequate contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) since their last menses * Agree to continue using adequate means of contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) for the duration of study participation * Females are not considered to be of childbearing potential if they are at least 1 year postmenopausal or have had a tubal ligation, bilateral oophorectomy or hysterectomy.
Exclusion criteria
* Active onychomycosis of the toenails or fingernails * Any of the following in the 4 weeks (or as indicated) prior to randomization: * Major surgery for any indication * Any personal history of: * Invasive cancer diagnosed or treated within the past 5 years. Participants who have been in remission for 5 years or more and have not required treatment in the past 5 years may be eligible if the principal investigator believes there is little to no risk of recurrence. * Concurrent use of the following medications or treatments * Other topical antifungals for any concomitant infection * Females who are pregnant or lactating. Should a woman become pregnant or suspect she is pregnant while she is participating in this study she should notify the study physician immediately. * Uncontrolled concurrent illness including ongoing or active infection, psychiatric illness or social situations that would limit compliance with study requirements or other underlying serious medical condition which, in the investigator's opinion, might preclude study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days | Baseline to 14 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) |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Jublia |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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)
Time frame: 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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Nail Polish and Efinaconazole Solution | 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 |
| Efinaconazole Solution, Nail Polish, and Top Coat | Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days | 5 days of stability | Standard Deviation 2 |
| Placebo Comparator: Nail Polish Only | Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days | 15 days of stability | Standard Deviation 0 |
| 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 | 5 days of stability | Standard Deviation 2 |