Onychomycosis of ToenailPhase 4NCT03110029
Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
A Phase 4 study testing Efinaconazole 10% Topical Application Solution [JUBLIA] and Application of Nail Polish in people with Onychomycosis of Toenail, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal infections in patients who wear polish compared to those who do not. Read more about this study
- Who is it for?
- Ages 19 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- Efinaconazole 10% Topical Application Solution [JUBLIA] and Application of Nail Polish
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female age 19-70, as 19 is the legal age in Alabama
- DLSO affecting at least 1 great toenail diagnosed with positive potassium hydroxide microscopy and culture of a dermatophyte
- Suitable for application of topical antifungal therapy, in the opinion of the investigator
- Target toenail thickness of 3 mm or less as measured by digital caliper, as thickness greater than 3 mm may allow inclusion of patient with severe onychomycosis, and this was the criteria used in the pivotal trial using topical efinaconazole for onychomycosis
- Women of childbearing potential will be required to use birth control and a negative urine pregnancy test must be documented prior to initiating treatment
Who cannot join
- History of immunosuppression or concurrent use of immunosuppressant drugs
- History of uncontrolled diabetes mellitus
- History of psoriasis or any other condition that might interfere with the toenail evaluation
- Three or more dermatophytomas (streaks) on the target nail
- Severe DLSO of the target nail
- Patients who cannot refrain from wearing gel or plastic based polishes that are used in salons and that require curing
Trial locations and contacts
1 site in 1 country.
About this study
This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal infections in patients who wear polish compared to those who do not.
Read the detailed description
Topical efinaconazole 10% solution is known to be an efficacious and safe treatment modality for toenail onychomycosis. This study will examine the compatibility of topical efinaconazole and nail polish in patients with distal and lateral subungual onychomycosis (DLSO). It is hypothesized that the treatment of DLSO with efinaconazole 10% solution will not be adversely affected by the application of nail polish.
- Conditions
- Onychomycosis of Toenail
- Being tested
- Efinaconazole 10% Topical Application Solution [JUBLIA], Application of Nail Polish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efinaconazole 10% Topical Application Solution [JUBLIA]Drug
Also called Jublia
Topical efinaconazole 10% solution (Jublia)
Application of Nail PolishOther
Application of Nail Polish
| Study group | Role | What they receive |
|---|---|---|
| Efinaconazole 10 % and Nail Polish | Active comparator | Subject will have Efinaconazole 10% solution application and nail polish Receives: Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]; Other: Application of Nail Polish |
| Efinaconazole 10% without Nail Polish | Placebo comparator | Subject will have only Efinaconazole 10% application and no nail polish Receives: Drug: Efinaconazole 10% Topical Application Solution [JUBLIA] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Nail Polish Disruption Using the Likert Scale
Patients will answer the following question:
Which will be answered using a Likert scale where 0 represents no alteration in polish and 10 represents complete destruction of the polish:
Is the quality of your polish diminished with use of Jublia?
Measured: 52 weeks
Secondary outcomes (1)
Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI)
Using 3rd party blinding, DLSO was assessed at baseline and at every subsequent visit using the onychomycosis severity index (OSI), measuring percent of the target nail involved, and grading the infection from mild to moderate to severe. The range for OSI is 0-20 with 20 indicating severe nails disease. Nail growth was measured at each visit. Fungal testing was done at screening, 3 months, 7 months, end of treatment (48 weeks), and end of study (52 weeks). Clinical and mycologic cure was evaluated at week 52.
Measured: 52 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startSep 2015
- Primary completionMay 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Onychomycosis of ToenailStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boni Elewski, MD, University of Alabama at Birmingham
- Investigators
- Boni E Elewski, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110029
- Sponsor's protocol ID
- X141114004
- Status last verified
- Jun 2019
- First submitted
- 16 Oct 2015
- Last updated
- 27 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
- ClinicalTrials.gov ID
- NCT03110029
- Acronym / sponsor ID
- X141114004
- Conditions
- Onychomycosis of Toenail
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 20 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal infections in patients who wear polish compared to those who do not.
Detailed description
Topical efinaconazole 10% solution is known to be an efficacious and safe treatment modality for toenail onychomycosis. This study will examine the compatibility of topical efinaconazole and nail polish in patients with distal and lateral subungual onychomycosis (DLSO). It is hypothesized that the treatment of DLSO with efinaconazole 10% solution will not be adversely affected by the application of nail polish.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efinaconazole 10 % and Nail Polish | Active comparator | Drug: Efinaconazole 10% Topical Application Solution [JUBLIA], Other: Application of Nail PolishSubject will have Efinaconazole 10% solution application and nail polish |
| Efinaconazole 10% without Nail Polish | Placebo comparator | Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]Subject will have only Efinaconazole 10% application and no nail polish |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female age 19-70, as 19 is the legal age in Alabama
- DLSO affecting at least 1 great toenail diagnosed with positive potassium hydroxide microscopy and culture of a dermatophyte
- Suitable for application of topical antifungal therapy, in the opinion of the investigator
- Target toenail thickness of 3 mm or less as measured by digital caliper, as thickness greater than 3 mm may allow inclusion of patient with severe onychomycosis, and this was the criteria used in the pivotal trial using topical efinaconazole for onychomycosis
- Women of childbearing potential will be required to use birth control and a negative urine pregnancy test must be documented prior to initiating treatment
Key exclusion criteria (6 listed)
- History of immunosuppression or concurrent use of immunosuppressant drugs
- History of uncontrolled diabetes mellitus
- History of psoriasis or any other condition that might interfere with the toenail evaluation
- Three or more dermatophytomas (streaks) on the target nail
- Severe DLSO of the target nail
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efinaconazole 10% Topical Application Solution [JUBLIA]Also: JubliaTopical efinaconazole 10% solution (Jublia) | Drug | Efinaconazole 10 % and Nail Polish, Efinaconazole 10% without Nail Polish |
| Application of Nail PolishApplication of Nail Polish | Other | Efinaconazole 10 % and Nail Polish |
Primary outcome
Percentage of Nail Polish Disruption Using the Likert Scale
Time frame: 52 weeks
Patients will answer the following question: Which will be answered using a Likert scale where 0 represents no alteration in polish and 10 represents complete destruction of the polish: Is the quality of your polish diminished with use of Jublia?
1 secondary outcome
Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI)
Time frame: 52 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boni E Elewski, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Efinaconazole 10% Topical Application Solution [JUBLIA] and Application of Nail Polish in people with Onychomycosis of Toenail, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Nail Polish Disruption Using the Likert Scale (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.