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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03280927

Enrollment

Registered

2017-09-13

Start date

2017-11-10

Completion date

2020-01-22

Last updated

2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to Moderate Onychomycosis Due to Dermatophyte

Keywords

Onychomycosis

Brief summary

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

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.

Interventions

DRUGJublia®

Jublia® topical solution

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Completely cured subjects	52 weeks	The ratio of completely cured subjects

Secondary

Measure	Time frame	Description
Complete or almost complete cure rates	52 weeks	The ratio of subjects showing less than 5% of infection area
Mycologic cure rates	52 weeks	Negative results from both the KOH Direct Microscopic Inspection and Fungi Cultivation Inspection.
Clinical efficacy rates	52 weeks	The ratio of subjects affected target nail area less than 10%

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026