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

• Status: Completed
• Trial end date: 2020-01-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Efinaconazole

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