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Japanese

Feb. 12, 2025

Nov. 12, 2025

jRCT2031240672

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

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

Kataoka Hiroya

Sato Pharmaceutical Co., Ltd.

1-5-27, Motoakasaka, Minato-Ku, Tokyo

+81-3-5412-7329

clinicaltrials-info@sato-seiyaku.co.jp

Clinical Trials Information Desk

Sato Pharmaceutical Co., Ltd.

1-5-27, Motoakasaka, Minato-Ku, Tokyo

+81-3-5412-7329

clinicaltrials-info@sato-seiyaku.co.jp

Not Recruiting

April. 03, 2025

April. 25, 2025
120

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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.

- 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.

18age old over
No limit

Both

Tinea pedis

Administer orally once daily for 4 weeks either a capsule containing 100 mg of hoslabconazole or a placebo capsule.

Cure rate at 12 weeks after the start of treatment.

Sato Pharmaceutical Co., Ltd.
Sugiura Clinic Institutional Review Board
4-4-16-301 Honcho, Kawaguchi City, Saitama, Saitama

+81-42-648-5551

Approval

Mar. 06, 2025

No

none

History of Changes

No Publication date
3 Nov. 12, 2025 (this page) Changes
2 July. 18, 2025 Detail Changes
1 Feb. 12, 2025 Detail