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

Mild to Moderate Onychomycosis Due to Dermatophyte Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280927
• Other study ID #: JBL_OM_IV
• Status: Completed
• Phase: Phase 4
• Start date: November 10, 2017
• Est. completion date: January 22, 2020

Study information

• Verified date: April 2021
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mild to Moderate Onychomycosis Due to Dermatophyte
• Onychomycosis

Intervention

Drug:
• Jublia®
Jublia® topical solution

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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