Real-World Evaluation of the Effect of Jublia on Nail Polish
1 other identifier
interventional
5
1 country
1
Brief Summary
A recent publication using cadaver nails suggests that Jublia application has a negative effect on nail polish texture.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 16, 2015
CompletedFirst Posted
Study publicly available on registry
January 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
January 6, 2020
CompletedJanuary 6, 2020
December 1, 2019
2 years
October 16, 2015
August 14, 2018
December 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Nail Polish + Efinaconazole Solution
ACTIVE COMPARATOROne big toe will receive application of Efinaconazole Solution on top of nail polish (without the presence of a top coat or base coat)
Nail Polish Only
PLACEBO COMPARATORBoth big toes will use nail polish only
Base Coat + Nail Polish + Top Coat + Efinaconazole Solution
ACTIVE COMPARATOROne big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.
Nail Polish + Top Coat + Efinaconazole Solution
ACTIVE COMPARATOROne big toe will receive application of Efinaconazole solution on top of nail polish with top coat.
Interventions
Application of Jublia to the nail of one big toe on top of the nail polish
Application of Jublia to the nail of one big toe on top of the nail polish with layers of top coat and base coat
Application of Jublia to the nail of one big toe on top of the nail polish with layer of top coat
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Kirklin Clinic
Birmingham, Alabama, 35249, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Director of Clinical Trials, UAB Dermatology
- Organization
- UAB
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 16, 2015
First Posted
January 18, 2017
Study Start
September 1, 2015
Primary Completion
September 1, 2017
Study Completion
December 1, 2017
Last Updated
January 6, 2020
Results First Posted
January 6, 2020
Record last verified: 2019-12