Clinical trial NCT03022916: Real-World Evaluation of the Effect of Jublia on Nail Polish
Official title: Real-World Evaluation of the Effect of Jublia on Nail Polish
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluation of Jublia on Nail Polish With Healthy Toenails
Keywords: toenail polish
jublia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days
timeFrame: Baseline to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Kirklin Clinic
state: Alabama
Study officials:
References: