Back to resultsPhase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis
Primary Purpose
Mild to Moderate Onychomycosis Due to Dermatophyte
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Jublia®
Sponsored by
About this trial
This is an interventional treatment trial for Mild to Moderate Onychomycosis Due to Dermatophyte focused on measuring Onychomycosis
Eligibility Criteria
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
Sites / Locations
- Konkuk University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Jublia®
Arm Description
Outcomes
Primary Outcome Measures
Completely cured subjects
The ratio of completely cured subjects
Secondary Outcome Measures
Complete or almost complete cure rates
The ratio of subjects showing less than 5% of infection area
Mycologic cure rates
Negative results from both the KOH Direct Microscopic Inspection and Fungi Cultivation Inspection.
Clinical efficacy rates
The ratio of subjects affected target nail area less than 10%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03280927
Brief Title
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Onychomycosis Due to Dermatophyte
Keywords
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Jublia®
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Jublia®
Intervention Description
Jublia® topical solution
Primary Outcome Measure Information:
Title
Completely cured subjects
Description
The ratio of completely cured subjects
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Complete or almost complete cure rates
Description
The ratio of subjects showing less than 5% of infection area
Time Frame
52 weeks
Title
Mycologic cure rates
Description
Negative results from both the KOH Direct Microscopic Inspection and Fungi Cultivation Inspection.
Time Frame
52 weeks
Title
Clinical efficacy rates
Description
The ratio of subjects affected target nail area less than 10%
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis
We'll reach out to this number within 24 hrs