UMIN ID: UMIN000001949
Registered date:08/05/2009
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 -
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Onychomycosis |
| Date of first enrollment | 2009/05/01 |
| Target sample size | 24 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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 2 drops to left and right first toenails and each one drop to all other toenails for 28 days. |
Outcome(s)
| Primary Outcome | KP-103 concentration in nails, onset of adverse effects and their severity |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1) Patient on corticosteroid (except external preparation for topical action to areas other than toenails is allowable) (2) Patient with problems in safety |
Related Information
| Primary Sponsor | KAKEN PHARMACEUTICAL CO.,LTD. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | KAKEN PHARMACEUTICAL CO.,LTD. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 2-28-8, Honkomagome, Bunkyo-ku, Tokyo, Japan Japan |
| Telephone | |
| Affiliation | KAKEN PHARMACEUTICAL CO.,LTD. Clinical Development Department |
| scientific contact | |
| Name | Shin-ichi Watanabe |
| Address | 2-11-1, Kaga, Itabashi-ku, Tokyo, Japan Japan |
| Telephone | |
| Affiliation | Graduated school of Medicine, Teikyo University Department of dermatology |