Skip to main content
OpenTrials
Completed

NCT Number: NCT03280927

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Konkuk University Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jublia®

Drug

Jublia® topical solution

Primary outcomes

  1. Completely cured subjects

    Time frame: 52 weeks

    The ratio of completely cured subjects

Secondary outcomes

  1. Complete or almost complete cure rates

    Time frame: 52 weeks

    The ratio of subjects showing less than 5% of infection area

  2. Mycologic cure rates

    Time frame: 52 weeks

    Negative results from both the KOH Direct Microscopic Inspection and Fungi Cultivation Inspection.

  3. Clinical efficacy rates

    Time frame: 52 weeks

    The ratio of subjects affected target nail area less than 10%

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2017
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.