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A study on measurement of KP-103 concentration in nails (Phase I) - Investigation of KP-103 concentration in nails following repeated topical application to toenails in patients with onychomycosis -

A study on measurement of KP-103 concentration in nails (Phase I) - Investigation of KP-103 concentration in nails following repeated topical application to toenails in patients with onychomycosis - - A study on measurement of KP-103 concentration in nails (Phase I)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001949
Enrollment
24
Registered
2009-05-08
Start date
2009-05-01
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

Once daily before bedtime KP-103 5% is applied each 2 drops to left and right first toenails and each one drop to all other toenails for 28 days. Once daily before bedtime KP-103 10% is applied each

Sponsors

KAKEN PHARMACEUTICAL CO.,LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patient with onychomycosis in either left or right first toenail or both, as demonstrated by mycological examination (direct KOH microscopy) and clinical symptoms (2) With or without left or right second toenail affected with onychomycosis (3) All types and severity of onychomycosis (4) Patient who can personally provide written informed consent

Exclusion criteria

Exclusion criteria: (1) Patient on corticosteroid (except external preparation for topical action to areas other than toenails is allowable) (2) Patient with problems in safety

Design outcomes

Primary

MeasureTime frame
KP-103 concentration in nails, onset of adverse effects and their severity

Countries

Japan

Outcome results

None listed

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