A double-blind comparative study of BFE1224 in patients with tinea pedis.

JRCT ID: jRCT2031240672

Registered date:12/02/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Tinea pedis
• Date of first enrollment: 03/04/2025
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Administer orally once daily for 4 weeks either a capsule containing 100 mg of hoslabconazole or a placebo capsule.

Outcome(s)

• Primary Outcome: Cure rate at 12 weeks after the start of treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Patients with tinea pedis in both feet or either foot.
- Patients who have been confirmed to have dermatophyte elements by direct microscopic examination.
- Patients in whom dermatophytes (Trichophyton species) have been identified by fungal culture.
- Japanese patients aged 18 years or older at the time of consent.

Exclude criteria

- Patients with clinically significant hepatic dysfunction.
- Patients with diseases or symptoms other than tinea pedis in the foot to be evaluated.
- Patients who have used oral antifungal agents within 12 weeks prior to obtaining consent, or who are currently using them.
- Patients who have used topical antifungal agents or topical treatments for onychomycosis on the foot to be evaluated within 4 weeks prior to obtaining consent, or who are currently using them.

Related Information

• Primary Sponsor: Kataoka Hiroya