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

NCT ID: NCT03022916

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-12-31

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.

Conditions

Evaluation of Jublia on Nail Polish With Healthy Toenails

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Nail Polish + Efinaconazole Solution

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

Group Type: ACTIVE_COMPARATOR

Nail Polish + Efinaconazole Solution

Intervention Type: DRUG

Application of Jublia to the nail of one big toe on top of the nail polish

Nail Polish Only

Both big toes will use nail polish only

Group Type: PLACEBO_COMPARATOR

Nail polish

Intervention Type: OTHER

Application of nail polish only to both big toe nails

Base Coat + Nail Polish + Top Coat + Efinaconazole Solution

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

Group Type: ACTIVE_COMPARATOR

Base Coat + Nail Polish + Top Coat + Efinaconazole Solution

Intervention Type: DRUG

Application of Jublia to the nail of one big toe on top of the nail polish with layers of top coat and base coat

Nail Polish + Top Coat + Efinaconazole Solution

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

Group Type: ACTIVE_COMPARATOR

Nail Polish + Top Coat + Efinaconazole Solution

Intervention Type: DRUG

Application of Jublia to the nail of one big toe on top of the nail polish with layer of top coat

Interventions

Nail Polish + Efinaconazole Solution

Application of Jublia to the nail of one big toe on top of the nail polish

Intervention Type: DRUG

Nail polish

Application of nail polish only to both big toe nails

Intervention Type: OTHER

Base 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

Intervention Type: DRUG

Nail 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

Intervention Type: DRUG

Other Intervention Names

Jublia; Jublia; Jublia

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Boni Elewski, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Kirklin Clinic

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

X150817005

Identifier Type: -

Identifier Source: org_study_id