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A phase 3 clinical study of HTU-520 in patients with onychomycosis.

A placebo-controlled, parallel group study of HTU-520 in patients with onychomycosis.

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221109
Enrollment
Unknown
Registered
2010-05-24
Start date
2010-05-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis

Interventions

investigational material(s) Generic name etc : HTU-520 (terbinafine hydrochloride-containing patch) INN of investigational material : Therapeutic category code : 629 Other chemotherapeutics Dosage an

Sponsors

Hisamitsu Pharmaceutical Co., Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients with involvement of nail - Patients who were found to have dermatophytosis of nail by direct microscopy - Patients in whom the dermatophyte infection of nail was identified

Exclusion criteria

Exclusion criteria: - Patients who used oral or injectable antifungal drugs within 36 weeks before informed consent was obtained - Patients who used topical antifungal drugs on the area to be examined or the surrounding area up to the distal joint within 4 weeks before informed consent was obtained - Patients who used terbinafine hydrochloride-containing topical antifungal drugs within 12 weeks before informed consent was obtained

Design outcomes

Primary

MeasureTime frame
Efficacy

Secondary

MeasureTime frame
Safety

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026