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

Dong-A ST

Status and phase: Completed; Phase 4

Conditions: Mild to Moderate Onychomycosis Due to Dermatophyte

Treatments: Drug: Jublia®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03280927

JBL_OM_IV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

97 participants in 1 patient group

Jublia®

Experimental group

Treatment:

Drug: Jublia®