Dermatophytosis, Onychomycosis
Conditions
Brief summary
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.
Interventions
DRUGJublia (Efinaconazole 10% Topical Solution)
Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Topical application of Jublia (Efinaconazole 10% Topical Solution) to patients with distal lateral subungual onychomycosis with dermatophytoma.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO) | week 48 | Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical or Mycological Cure of Nail | week 48 | Completely normal nail plate or negative fungal culture |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Baseline Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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.
Time frame: week 48
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Group | Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO) | 19 Participants |
Secondary
Clinical or Mycological Cure of Nail
Completely normal nail plate or negative fungal culture
Time frame: week 48
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Group | Clinical or Mycological Cure of Nail | 12 Participants |