Real-World Evaluation of the Effect of Jublia on Nail Polish

The University of Alabama at Birmingham

Status: Completed

Conditions: Evaluation of Jublia on Nail Polish With Healthy Toenails

Treatments: Drug: Nail Polish + Top Coat + Efinaconazole Solution; Drug: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution; Drug: Nail Polish + Efinaconazole Solution; Other: Nail polish

Study type: Interventional

Funder types: Other

Identifiers

NCT03022916

X150817005

Details and patient eligibility

About

A recent publication using cadaver nails suggests that Jublia application has a negative effect on nail polish texture.

Full 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.

Enrollment: 5 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 4 patient groups, including a placebo group

Nail Polish + Efinaconazole Solution

Active Comparator group

Description:

One big toe will receive application of Efinaconazole Solution on top of nail polish (without the presence of a top coat or base coat)

Treatment:

Drug: Nail Polish + Efinaconazole Solution

Nail Polish Only

Placebo Comparator group

Description:

Both big toes will use nail polish only

Treatment:

Other: Nail polish

Base Coat + Nail Polish + Top Coat + Efinaconazole Solution

Active Comparator group

Description:

One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.

Treatment:

Drug: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution

Nail Polish + Top Coat + Efinaconazole Solution

Active Comparator group

Description:

One big toe will receive application of Efinaconazole solution on top of nail polish with top coat.

Treatment:

Drug: Nail Polish + Top Coat + Efinaconazole Solution