Status:
COMPLETED
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Mild to Moderate Onychomycosis Due to Dermatophyte
Eligibility:
All Genders
19+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2020
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT03280927
Start Date
November 10 2017
End Date
January 22 2020
Last Update
April 27 2021
Active Locations (1)
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1
Konkuk University Medical Center
Seoul, South Korea