Trial reportThe Journal of dermatology2018
Efficacy and safety of fosravuconazole L-lysine ethanolate, a novel oral triazole antifungal agent, for the treatment of onychomycosis: A multicenter, double-blind, randomized phase III study.
Trial report in The Journal of dermatology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 78 citations in OpenAlex.
- Trial
- Antifungal pulse therapy for onychomycosis: a narrative review.European journal of clinical pharmacology · 2026Review
- Resistance and Recalcitrance in Dermatophytosis: Mechanistic and Clinical Considerations for Keratinized Tissues.Antibiotics (Basel, Switzerland) · 2026Review
- New and Investigational Treatment Options for Dermatomycosis in the Era of Antifungal Resistance.Journal of fungi (Basel, Switzerland) · 2026Review
- Molecular docking approaches in mycetoma: Toward improved patient management.PLoS neglected tropical diseases · 2026Review
- A drug-repurposing screen of FDA- and EMA-approved drugs identifies two NF-κB inhibitors active against eumycetoma.The Journal of antimicrobial chemotherapy · 2025Article
- Progress and Prospects of Triazoles in Advanced Therapies for Parasitic Diseases.Tropical medicine and infectious disease · 2025Review
- Kidney injury associated with fosravuconazole L-lysine ethanolate.Clinical and experimental nephrology · 2025Article
- Azole Combinations and Multi-Targeting Drugs That Synergistically InhibitJournal of fungi (Basel, Switzerland) · 2024Review
- Risk factors for the development of tinea pedis and onychomycosis: Real-world evidence from a single-podiatry center, large-scale database in Japan.The Journal of dermatology · 2024Article
- Antifungal Selection for the Treatment of Onychomycosis: Patient Considerations and Outcomes.Infection and drug resistance · 2024Review
- Onychomycosis: Old and New.Journal of fungi (Basel, Switzerland) · 2023Review
- The pipeline for drugs for control and elimination of neglected tropical diseases: 1. Anti-infective drugs for regulatory registration.Parasites & vectors · 2023Review
- A severe case ofMedical mycology case reports · 2022Article
- Augmenting Azoles with Drug Synergy to Expand the Antifungal Toolbox.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Updated Perspectives on the Diagnosis and Management of Onychomycosis.Clinical, cosmetic and investigational dermatology · 2022Review
- Clinical effectiveness of efinaconazole 10% solution for treatment of onychomycosis with longitudinal spikes.The Journal of dermatology · 2021Article
- Cluster Infection Caused by a Terbinafine-resistant Dermatophyte at a Group Home: The First Case Series in Japan.Acta dermato-venereologica · 2021Article
- Treatment Outcome with Fosravuconazole for Onychomycosis.Mycopathologia · 2021Article
- Innovation in the discovery of the HIV-1 attachment inhibitor temsavir and its phosphonooxymethyl prodrug fostemsavir.Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents · 2021Review
Corrections and comments
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Authors and funding
3 authors at 2 institutions in 1 country.
Funding
Abstract
Fosravuconazole L-lysine ethanolate (F-RVCZ) is a prodrug of ravuconazole, a novel triazole antifungal agent, exerting broad and potent antifungal activity. The efficacy and safety of F-RVCZ, compared with a placebo, were investigated in a multicenter, double-blind, randomized study of Japanese onychomycosis patients with 25% or more clinical involvement of the target toenail. Subjects (n = 153) were randomly assigned to receive F-RVCZ (100 mg RVCZ, n = 101) or placebo (n = 52) p.o. once daily for 12 weeks. The primary end-point was the rate of complete cure (clinical cure [0% clinical involvement of the target toenail] plus mycological cure [negative potassium hydroxide examination]) at week 48 (36-week post-treatment visit). Secondary end-points were changes over time in the efficacy and mycological effect of F-RVCZ. Safety was also evaluated. The complete cure rate at week 48 was significantly higher with F-RVCZ (59.4%, 60/101) than the placebo (5.8%, 3/52) in the full analysis set (P < 0.001). The mycological cure rate at week 48 was also significantly higher with F-RVCZ (82.0%, 73/89) than the placebo (20.0%, 10/50, P < 0.001). Regarding safety, adverse events were observed in 83.2% (84/101) and 80.8% (42/52), and adverse drug reactions (ADR) in 23.8% (24/101) and 3.8% (2/52) of F-RVCZ and placebo subjects, respectively. ADR were mild to moderate in severity, with none being serious. F-RVCZ (equivalent to 100 mg ravuconazole) administrated once daily for 12 weeks was more effective than placebo and tolerable in patients with onychomycosis, suggesting it to be a promising drug for onychomycosis treatment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.