Drug updated on 12/11/2024
Dosage Form | Solution (topical: 10%) |
Drug Class | Azole antifungals |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes.
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Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Efinaconazole 10% solution demonstrated higher effectiveness than vehicle in achieving complete cure (relative risk (RR) 3.54, 95% confidence interval (CI) 2.24 to 5.60; high-quality evidence), clinical cure (RR 3.07, 95% CI 2.08 to 4.53; high-quality evidence), and mycological cure (RR 2.31, 95% CI 1.08 to 4.94; moderate-quality evidence).
- Tavaborole 5% solution likely increases complete cure rates (RR 7.40, 95% CI 2.71 to 20.24; moderate-quality evidence) and mycological cure rates (RR 3.40, 95% CI 2.34 to 4.93; high-quality evidence) compared to vehicle.
- Ciclopirox 8% lacquer may be more effective than vehicle for complete cure (RR 9.29, 95% CI 1.72 to 50.14; low-quality evidence) and likely improves mycological cure (RR 3.15, 95% CI 1.93 to 5.12; moderate-quality evidence).
- Efinaconazole 10% solution showed a slightly higher risk of adverse events, including dermatitis and vesicles (RR 1.10, 95% CI 1.01 to 1.20; high-quality evidence), while tavaborole 5% solution likely increased application site reactions (RR 3.82, 95% CI 1.65 to 8.85; moderate-quality evidence).
- Ciclopirox 8% lacquer and luliconazole 5% solution showed varying adverse event profiles, with ciclopirox potentially leading to application reactions and rashes (RR 1.61, 95% CI 0.89 to 2.92; low-quality evidence) and luliconazole showing minimal difference in adverse events compared to vehicle (RR 1.02, 95% CI 0.90 to 1.16; low-quality evidence).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Jublia (efinaconazole) Prescribing Information. | 2022 | Bausch Health US LLC, Bridgewater, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Understanding Global Access to Topical Onychomycosis Therapy: A Systematic Review and Meta-Analysis | 2024 | Mycoses |
Topical and device-based treatments for fungal infections of the toenails | 2020 | The Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Therapeutic recommendations for the treatment of toenail onychomycosis in the US. | 2021 | Journal of Drugs in Dermatology |