Efficacy of Fosravuconazole, an oral antifungal agent, in the treatment of tinea pedis

JRCT ID: jRCTs031220578

Registered date:19/01/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Tinea pedis of interdigital and vesicular type, Tinea pedis of keratotic type
• Date of first enrollment: 22/02/2023
• Target sample size: 100
• Study type: Interventional

Intervention(s)

(1) Tinea pedis of interdigital and vesicular type
One capsule (100 mg ravuconazole) is administered orally once daily for one week (7 days) and evaluated at 1, 4, and 8 weeks of treatment.

(2) Tinea pedis of keratotic type
One capsule (100 mg ravuconazole) is administered orally once daily for 4 weeks (28 days) and evaluated at 4, 8, and 12 weeks of treatment.

Outcome(s)

Primary Outcome

1) Tinea pedis of interdigital and vesicular type: Overall clinical response after four weeks of treatment
2) Tinea pedis of keratotic type: Overall clinical response after eight weeks of treatment

Secondary Outcome

1) Overall clinical efficacy after completion of follow-up
Tinea pedis of interdigital and vesicular type: Overall clinical efficacy after 8 weeks of treatment
Tinea pedis of keratotic type: Overall clinical efficacy after 12 weeks of treatment
2) Mycological examination (mycological efficacy): at the time of efficacy determination and at the time of follow-up evaluation
3) Degree of improvement of clinical symptoms: at the time of efficacy determination and at the time of follow-up evaluation
4) Changes in tinea pedis symptoms
Compare and evaluate changes over time.
5) Patient satisfaction
Evaluation using the Japanese version of TSQM-9.
Scores for "effectiveness," "convenience," and "general satisfaction" will be evaluated according to the TSQM-9 criteria.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

The subjects of this study will be patients with tinea pedis who meet all of the following criteria.
1) Patients with tinea pedis (interdigital type, vesicular type, keratotic type) on either foot or both sides of the foot.
(The diagnosis of tinea pedis requires confirmation of the dermatophyte element by direct speculum examination.)
*In patients with tinea pedis on both feet, the side with more severe clinical symptoms of tinea pedis should be selected for observation.
2) Patients who are at least 18 years on the date of consent
3) Patients with written consent to participate in the study after the details of the study have been explained to them.
Patients with other concurrent skin fungal infections, such as tinea cruris and tinea corporis, may be enrolled in the study. However, the concomitant diseases and their standard treatment methods will be explained to the subjects. If the subjects desire, treatment will be provided through regular medical care after the observation period.

Exclude criteria

Patients with the following exclusion criteria will be excluded from the study.
1) Patients with a history of hypersensitivity to the drugs under study
2) Patients with severe eczema, erosions, maceration, abscesses, etc., on the affected area of tinea pedis requiring topical treatment other than antifungal agents
3) Patients with complications such as secondary infection of tinea pedis
4) Patients who have used oral antifungal agents within three months before the start of the study
5) Patients who used topical antifungal agents or topical onychomycosis agents within one month before the start of the study
6) Patients with hepatic impairment (or clinically problematic hepatic dysfunction), AST or ALT greater than 2.5 times the upper reference limit of the laboratory, or AST or ALT greater than 100 U/L
7) Patients with clinically problematic renal dysfunction, such as creatinine of 2.0 mg/dL or higher
8) Patients receiving warfarin
9) Patients suffering from serious systemic diseases (severe diabetes, autoimmune diseases such as collagen diseases, hematological diseases, and malignant tumors)
10) Patients receiving systemic immunosuppressive drugs (steroids, tacrolimus, cyclosporine, methotrexate, JAK inhibitors, PDE4 inhibitors, biological agents, etc.)
11) Pregnant or possibly pregnant patients, lactating patients, or patients who wish to become pregnant during the study period
12) Patients who have participated or are participating in other clinical trials or clinical studies within six months
13) Patients deemed ineligible for this study by the principal investigator or sub-investigator

Related Information

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