A Phase 4 interventional study of Jublia (Efinaconazole 10% Topical Solution) in Onychomycosis and Dermatophytosis, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-10.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment
This study will examine how Jublia affects dermatophytomas, which are difficult to treat with other therapeutic options.
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.
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's enrollment of 19 is below the median of 60 across 143 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The application of other topical medications or cosmetic products to the toenail Professional pedicures for the duration of the study. - Females of must: Have been using adequate (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 or have had a tubal ligation, bilateral oophorectomy or hysterectomy.
Exclusion Criteria:
Major surgery for any indication
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with distal lateral subungual onychomycosis (DLSO) with dermatophytoma.
Drug: Jublia (Efinaconazole 10% Topical Solution)
Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.
Also known as: Jublia
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.
Time frame: week 48
Clinical or Mycological Cure of Nail
Completely normal nail plate or negative fungal culture
Time frame: week 48
| Milestone | Jublia Treatment Group |
|---|---|
| Started | 19 |
| Completed | 17 |
| Not completed | 2 |
Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.
| Participants | Baseline Group |
|---|---|
| Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO) | 19 |
Completely normal nail plate or negative fungal culture
| Participants | Jublia (Efinaconazole 10% Topical Solution) + Nail Polish |
|---|---|
| Clinical or Mycological Cure of Nail | 12 |
Collected over 48 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Baseline Group | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Baseline Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 16 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | Baseline Group |
|---|---|
| Female | 7 |
| Male | 12 |
| Race (NIH/OMB)(Participants) | Baseline Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Baseline Group |
|---|---|
| United States | 19 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Sep 2015, a primary completion of May 2017 and a completion of Jul 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2019, 1 year 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Efinaconazole
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