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
Not provided
Not provided
Not provided
Not provided
The antifungal efficacy and safety of Jublia® topical solution will be assessed through an administration for 48 weeks to patients diagnosed with a mild or moderate onychomycosis due to dermatophyte.
Evaluate anti-fungal activity and safety of efinaconazole in patients with mild to moderate toenail onychomycosis caused by dermatophytes that received a 48-week administration of efinaconazole.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jublia® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jublia® | Drug | Jublia® topical solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completely cured subjects | The ratio of completely cured subjects | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complete or almost complete cure rates | The ratio of subjects showing less than 5% of infection area | 52 weeks |
| Mycologic cure rates | Negative results from both the KOH Direct Microscopic Inspection and Fungi Cultivation Inspection. |
Not provided
Inclusion Criteria:
Adult male and female subjects of ages in the range over 19.
The subjects diagnosed with onychomycosis in up to 6 toenails at least
1 great toenail woth no fingernails
The subjects diagnosed with a mild to moderate onychomycosis (20% to 50% of surface of target nail without nail matrix infection or dermatophytoma)
The subjects having target nails less than 3mm in thickness and over 3mm in length
Positive indication on KOH Direct Microscopic Inspection on target nail
Positive dermatophyte or dermatophyte/candida on Fungi Cultivation Inspection on target nail
The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Seoul | South Korea |
Not provided
| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| C431707 | efinaconazole |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 52 weeks |
| Clinical efficacy rates | The ratio of subjects affected target nail area less than 10% | 52 weeks |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |