Clinical research of CLENAFI
- Conditions
- Trichophytosis unguium
- Registration Number
- JPRN-UMIN000024268
- Lead Sponsor
- KAKEN PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 223
Not provided
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time course of Clinical efficacy rate, defined as 10% or less affected target nail area
- Secondary Outcome Measures
Name Time Method 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