OnychomycosisPhase 4NCT03098615
Study Evaluating the Effect of Jublia on Dermatophytomas
A Phase 4 study testing Jublia (Efinaconazole 10% Topical Solution) in people with Onychomycosis and Dermatophytosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will examine how Jublia affects dermatophytomas, which are difficult to treat with other therapeutic options. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis, Dermatophytosis
- What is being tested?
- Jublia (Efinaconazole 10% Topical Solution)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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, intrauterine device (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.
Who cannot join
- 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/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 locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator Initiated Pilot Study Evaluating the Efficacy of Efinaconazole 10% Solution (Jublia) for the Treatment of Onychomycosis With Dermatophytomas
This study will examine how Jublia affects dermatophytomas, which are difficult to treat with other therapeutic options.
Read the detailed description
Dermatophytomas are known to be resistant to even long courses of systemic antifungals, and have therefore been excluded from both topical and systemic clinical trials for onychomycosis, including those for Efinaconazole solution. Efinaconazole (Jublia) 10% solution is an FDA approved topical medication indicated for treatment of distal lateral subungual onychomycosis (DLSO), and the utility of this medication likely exceeds published results. Efinaconazole solution's novel ability to penetrate into the subungual space likely accounts for improved treatment results seen in DLSO treated with Jublia. We will investigate the utility of topical efinaconazole solution in the treatment of dermatophytomas.
- Conditions
- Onychomycosis, Dermatophytosis
- Being tested
- Jublia (Efinaconazole 10% Topical Solution)
- Medical subject headings
- Onychomycosis, Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jublia (Efinaconazole 10% Topical Solution)Drug
Also called Jublia
Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.
| Study group | Role | What they receive |
|---|---|---|
| Jublia (Efinaconazole 10% Topical Solution) + nail polish | Other | Subjects with distal lateral subungual onychomycosis (DLSO) with dermatophytoma. Receives: Drug: Jublia (Efinaconazole 10% Topical Solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO)
Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.
Measured: week 48
Secondary outcomes (1)
Clinical or Mycological Cure of Nail
Completely normal nail plate or negative fungal culture
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 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 OnychomycosisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Topical application of Jublia (Efinaconazole 10% Topical Solution) to patients with distal lateral subungual onychomycosis with dermatophytoma.
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT03098615
- Sponsor's protocol ID
- F150408010
- Status last verified
- Nov 2019
- First submitted
- 16 Oct 2015
- Last updated
- 10 Dec 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 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated Pilot Study Evaluating the Efficacy of Efinaconazole 10% Solution (Jublia) for the Treatment of Onychomycosis With Dermatophytomas
- ClinicalTrials.gov ID
- NCT03098615
- Acronym / sponsor ID
- F150408010
- Conditions
- Onychomycosis, Dermatophytosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 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
- 4 Apr 2017 (actual)
- Results
- Posted 19 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 examine how Jublia affects dermatophytomas, which are difficult to treat with other therapeutic options.
Detailed description
Dermatophytomas are known to be resistant to even long courses of systemic antifungals, and have therefore been excluded from both topical and systemic clinical trials for onychomycosis, including those for Efinaconazole solution. Efinaconazole (Jublia) 10% solution is an FDA approved topical medication indicated for treatment of distal lateral subungual onychomycosis (DLSO), and the utility of this medication likely exceeds published results. Efinaconazole solution's novel ability to penetrate into the subungual space likely accounts for improved treatment results seen in DLSO treated with Jublia. We will investigate the utility of topical efinaconazole solution in the treatment of dermatophytomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Topical application of Jublia (Efinaconazole 10% Topical Solution) to patients with distal lateral subungual onychomycosis with dermatophytoma.
| Arm | Type | Receives |
|---|---|---|
| Jublia (Efinaconazole 10% Topical Solution) + nail polish | Other | Drug: Jublia (Efinaconazole 10% Topical Solution)Subjects with distal lateral subungual onychomycosis (DLSO) with dermatophytoma. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Jublia (Efinaconazole 10% Topical Solution)Also: JubliaEfinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma. | Drug | Jublia (Efinaconazole 10% Topical Solution) + nail polish |
Primary outcome
Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO)
Time frame: week 48
Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.
1 secondary outcome
Clinical or Mycological Cure of Nail
Time frame: week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 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 Jublia (Efinaconazole 10% Topical Solution) in people with Onychomycosis and Dermatophytosis, 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 8 inclusion and 7 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 10 Dec 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. 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 19 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?
Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO) (time frame: week 48). 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 10 Dec 2019.