Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter, Open-label, Non-controlled, Single-arm Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis

Conditions
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Mild to Moderate Onychomycosis Due to Dermatophyte

Intervention / Treatment
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* Drug: Jublia®


Participation Criteria
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Eligibility Criteria
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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: The subjects suffering other diseases that may cause nail abnormalities or are supposed to be affecting the assessment of the efficacy of study agent by the judgment of investigators The subjects having a case history of hypersensitivity reaction to the component of Jublia® topical solution or Azole derivatives. The pregnant, lactating, or fertile woman free from pertinent contraception

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jublia®<br> | Drug: Jublia®<br>* Jublia® topical solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completely cured subjects | The ratio of completely cured subjects | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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. | 52 weeks | 
| Clinical efficacy rates | The ratio of subjects affected target nail area less than 10% | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Onychomycosis