Skip to content

Clinical research evaluating efficiency of detection for antigen of tinea by trichophyton antigen kit in tinea unguium.

Clinical research evaluating efficiency of detection for antigen of tinea by trichophyton antigen kit in tinea unguium. - Clinical research evaluating efficiency of trichophyton antigen kit in tinea unguium.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000038613
Enrollment
168
Registered
2019-11-18
Start date
2019-11-06
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

Tinea Unguium

Interventions

None listed

Sponsors

Maruho Co., Ltd.
Lead Sponsor
JNC CORPORATION Linical Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients enrolled in the study must meet the following 1)2)3)and 5)or 1)2)4)and 5). 1)Patients aged at least 20 years at the time of enrolment. 2)Patients who have understood the purpose of the study and provided written informed consent for participation in this study. 3)Patients who diagnosed as tinea unguium by KOH direct microscopy. The disease types are all types(DLSO,SWO,PSO,TDO). Specifically, positive is defined as the presence of fungal elements discovered by KOH direct microscopy at a magnification of 100 times. "Weakly positive(+)" is the case that single dermatophyte is discovered in multiple field, and "strongly positive(++)"is the case that multiple dermatophyte are discovered in multiple field. 4)Patients who diagnosed as non tines unguium by KOH direct microscopy for other diseases in the nail area(for example malformed nail). 5)Patients who has residual samples which is collected at the time of KOH direct microscopy at usual clinical care.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study. 1)Patients who has received oral antifungal drugs within 6 months(180 days) or patient who has received antifungal agent for external use within a month(30 days) prior to the enrolment. 2)Patients who participates in other clinical studies(except for observational study). 3)Patients determined to be inappropriate to be enrolled in this study by investigators.

Design outcomes

Primary

MeasureTime frame
Concordance and discordance rates between the detection results of antigen of tinea by trichophyton antigen kit and the diagnosis of tinea unguium by KOH direct microscopy.

Countries

Japan

Contacts

Public ContactFuminobu Tomonari

Linical Co., Ltd. Contract Medical Affairs Unit, Clinical Trail Operations

tomonari-fuminobu@linical.co.jp03-6215-8005

Outcome results

None listed

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