Usefulness of additional treatment after oral drug treatment for complete cure of Onychomycosis.

JRCT ID: jRCTs031200047

Registered date:08/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Onychomycosis
• Date of first enrollment: 22/07/2020
• Target sample size: 318
• Study type: Interventional

Intervention(s)

1) Fosravuconazole treatment and evaluation period (first oral administration to Week 24)
Oral administration of fosravuconazole once a day (100 mg of ravuconazole) for 12 weeks, and 12 weeks after the end of oral administration (24 weeks after the start of oral administration) will be evaluated.

2) Fosravuconazole additional effect evaluation period (after Week 24 from the first oral administration, up to Week 72)
(1) Opacity ratio reduction rate: 55% or more
Group X: Follow-up (without drug treatment)
(2) Opacity ratio reduction rate: less than 55% or more
Group A: Follow-up (without drug treatment)
Group B: Additional oral administration of fosravuconazole and follow-up

Outcome(s)

• Primary Outcome: Complete cure rate 72 weeks after the start of treatment

Secondary Outcome

1) Time to complete cure
2) Change of opacity area ratio, opacity ratio
3) Effective rate (remarkable effective and effective) and cure rate (clinical and mycological)
4) Nail growth speed
5) Patient satisfaction

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who are affected with onychomycosis on the first toenail of either the left or right
2) Patients with opacity ratio of opacity lesion of the first toe nail are 5 or more
3) Patients aged at least 20 years of age at the consent day
4) Patients who provided written consent for participation in the study

Exclude criteria

1) Patients with a known hypersensitivity to any excipients of the study drugs
2) When the target toenail is classified into the below subtypes Wedge shape
Total dystrophic onychomycosis (TDO)
Superficial white onychomycosis (SWO)
Proximal subungual onychomycosis (PSO)
3) When the target toenail is extremely thickened or deformed
4) Patients who had or have diagnosed as psoriasis, palmoplantar pustulosis
5) Patients with dermatological diseases (exp: lichen planus) showing thickened or involved toenails.
6) Patients who received oral or topical anti-onychomycotic drugs within 3 months before the first administration of the study drug
7) Patients who received topical anti-fungal drugs within a month before the first administration of the study drug
8) Patients with hepatic disorder (or show clinically important impairment of liver function), or who show AST or ALT more than 2.5 times higher values compared to the upper limit of normal values or who show AST or ALT more than 100U/L.
9) Patients who are receiving warfarin
10) Pregnant or possibly pregnant women, breastfeeding women, or women who wish to become pregnant during the study
11) Patients who are participating or participated into other clinical studies in the past 6 months
12) Patients that it is judged by the investigators that participation into this study is inappropriate

Related Information

• Primary Sponsor: Naka Wataru
• Secondary Sponsor: Igarashi Atsuyuki,Tsunemi Yuichiro
• Source(s) of Monetary Support: Sato Pharmaceutical Co.,Ltd