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

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

Study Overview

• Status: Completed
• Conditions: Evaluation of Jublia on Nail Polish With Healthy Toenails
• Intervention / Treatment: Drug: Nail Polish + Efinaconazole Solution; Other: Nail polish; Drug: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution; Drug: Nail Polish + Top Coat + Efinaconazole Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • The Kirklin Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Drug: Nail Polish + Efinaconazole Solution; Application of Jublia to the nail of one big toe on top of the nail polish; Other Names: Jublia
Placebo Comparator: Nail Polish Only; Both big toes will use nail polish only	Other: Nail polish; Application of nail polish only to both big toe nails
Active Comparator: 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.	Drug: 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; Other Names: Jublia
Active Comparator: Nail Polish + Top Coat + Efinaconazole Solution; One big toe will receive application of Efinaconazole solution on top of nail polish with top coat.	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; Other Names: Jublia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline to 14 days

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: toenail polish; jublia
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antifungal Agents; Pharmaceutical Solutions; Efinaconazole
• Other Study ID Numbers: X150817005