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

April 26, 2021 updated by: Dong-A ST Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jublia®
Drug: Jublia®
Jublia® topical solution

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2017

Primary Completion (Actual)

January 22, 2020

Study Completion (Actual)

January 22, 2020

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JBL_OM_IV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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