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

Phase 4

Completed

• Conditions: Mild to Moderate Onychomycosis Due to Dermatophyte
• Interventions: Drug: Jublia®

• Registration Number: NCT03280927
• Lead Sponsor: Dong-A ST Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Study Start: 2017-11-10
• Primary Completion: 2020-01-22
• Study Completion: 2020-01-22
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Jublia®	Jublia®	-

Primary Outcome Measures

Name	Time	Method
Completely cured subjects	52 weeks	The ratio of completely cured subjects

Secondary Outcome Measures

Name	Time	Method
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%

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of