Trichophytosis unguium
Conditions
Interventions
CLENAFIN is to be applied once daily until Clinical Cure(up to 72 weeks)
Sponsors
KAKEN PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, Verbal and written informed consent obtained from the patient. 2. Male or female, 20 years or older 3. Has a positive KOH examination at the site from the target nail. 4. Clinically diagnosed trichophytosis unguium of at least one great toenail (the "target nail") and 20% and over of target nail area have clinically affected as determined by investigator. 5. Target nail has evidence of nail growth, per patient's report that monthly clipping is needed.
Exclusion criteria
Exclusion criteria: 1. Clinically diagnosed Proximal Subungual Onychomycosis (PSO) or Total Dystrophic Onychomycosis (TDO). 2. Presence of any nail abnormalities without trichophytosis unguium (e.g. nail psoriasis, lichen planus affecting nails, traumatic onychodystrophy) as determined by the investigator. 3. Treatment with CLENAFIN, oral antifungal drugs or antifungal agent for external use within 3 months prior to informed consent. 4. Plannning to receive the following treatment during the study period: (1) oral antifungal drug (2) antifungal agent for external use without CLENAFIN. (3) laser radiation (4) occlusive dressing technique (e.g. urea ointment) 5. Has a negative fungal culture at the central mycology lab. (confirmed by investigator after the subjects' informed consent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time course of Clinical efficacy rate, defined as 10% or less affected target nail area | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Time course of Clinical Cure rate, defined as zero% involvement of the target nail in addition to Mycologic Cure, defined as negative KOH examination 2) Time course of increasing ratio in health (unaffected) area rate of the target nail 3) Time course of Mycologic Cure rate, difined as negative KOH examination of the target nail 4) Change of QOL score 5) Changes over time in the decrease rate of clinical involvement 6) Changes over time in the clinical involvement | — |
Countries
Japan
Contacts
Public ContactHiroshi Morifuji
RPM Co., Ltd. Clinical Development division
Outcome results
None listed