Unique ID issued by UMIN | UMIN000024268 |
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Receipt number | R000027939 |
Scientific Title | Clinical research of CLENAFIN |
Date of disclosure of the study information | 2016/10/17 |
Last modified on | 2019/07/11 12:11:38 |
Clinical research of CLENAFIN
Clinical research of CLENAFIN
Clinical research of CLENAFIN
Clinical research of CLENAFIN
Japan |
Trichophytosis unguium
Dermatology |
Others
NO
To examine the following which were not evaluated in the clinical trial of CLENAFIN and to provide the necessary information in clinical practice.
1) the efficacy of administered CLENAFIN in the treatment of trichophytosis unguium patients which have great toenails being clinically affected more than 50% of the tonail area.
2) the efficacy of more than 48 weeks of administered CLENAFIN.
by evaluating the efficacy of up to 72 weeks of topically administered CLENAFIN in the treatment of trichophytosis unguium patients which have great toenails being clinically affected 20% and over of the tonail area.
Efficacy
Time course of Clinical efficacy rate, defined as 10% or less affected target nail area
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
CLENAFIN is to be applied once daily until Clinical Cure(up to 72 weeks)
20 | years-old | <= |
Not applicable |
Male and Female
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.
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)
200
1st name | |
Middle name | |
Last name | Nobuyuki Kodera |
KAKEN PHARMACEUTICAL CO., LTD.
Clinical Development Depertment
28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
03-5977-5111
kodera_nobuyuki@kaken.co.jp
1st name | |
Middle name | |
Last name | Hiroshi Morifuji |
RPM Co., Ltd.
Clinical Development division
3-2-4, Nishi-shinjuku,Shinjuku-ku,Tokyo, Japan
03-5325-5821
clenafin-cr1@rpmedical.co.jp
KAKEN PHARMACEUTICAL CO., LTD.
KAKEN PHARMACEUTICAL CO., LTD.
Profit organization
NO
2016 | Year | 10 | Month | 17 | Day |
Published
223
Completed
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 10 | Month | 27 | Day |
2017 | Year | 01 | Month | 05 | Day |
2018 | Year | 12 | Month | 03 | Day |
2016 | Year | 10 | Month | 03 | Day |
2019 | Year | 07 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027939
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