Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jublia (Efinaconazole 10% Topical Solution) + nail polish | Other | Subjects with distal lateral subungual onychomycosis (DLSO) with dermatophytoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jublia (Efinaconazole 10% Topical Solution) | Drug | Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical or Mycological Cure of Nail | Completely normal nail plate or negative fungal culture | week 48 |
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boni E Elewski, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirklin Clinic | Birmingham | Alabama | 35249 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Jublia Treatment Group | The intervention to be administered is Jublia (Efinaconazole 10% Topical Solution). The frequency of administration is daily to the affected toes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Group | Subject with age >18, provision of informed consent, presence of dermatophytoma on one or both great toenails, target great to-nail thickness <= 3.0 mm, positive potassium hydroxide (KOH) or culture. Exclusion based upon history of immunosuppression, history of psoriasis of the nail, other nail disease, 3 or more dermatophytomas, unwillingness to avoid nail polish |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | week 48 |
|
|
48 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline Group | Subject with age >18, provision of informed consent, presence of dermatophytoma on one or both great toenails, target great to-nail thickness <= 3.0 mm, positive KOH or culture. Exclusion based upon history of immunosuppression, history of psoriasis of the nail, other nail disease, 3 or more dermatophytomas, unwillingness to avoid nail polish |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Roop | UAB | 2059754917 | lmroop@uabmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2017 | Feb 27, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| D014005 | Tinea |
| ID | Term |
|---|---|
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C431707 | efinaconazole |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Topical application of Jublia (Efinaconazole 10% Topical Solution) to patients with distal lateral subungual onychomycosis with dermatophytoma.
Not provided
Not provided
Not provided
Not provided
|
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Clinical or Mycological Cure of Nail | Completely normal nail plate or negative fungal culture | Posted | Count of Participants | Participants | week 48 |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
Not provided
Not provided
| D012874 |
| Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |