Trial reportMycoses2025
A Double-Blind Randomised Clinical Trial of Terbinafine-Nanostructured Lipid Carriers: Should We Anticipate This Strategy for Effective Topical Treatment of Onychomycosis?
Trial report in Mycoses, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
2 citing papers in PubMed.
- Trial
- New and Investigational Treatment Options for Dermatomycosis in the Era of Antifungal Resistance.Journal of fungi (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundOral terbinafine (TBF) is the drug of choice for onychomycosis management. To treat and heal the rough and thick nail tissue affected by fungal agents, a high dose and plasma concentration of this drug is necessary. This, however, poses a life-threatening risk due to the cytotoxic side effects, drug-drug interactions, and adverse physical and chemical properties associated with oral medications.
objectivesThis study aimed to employ nanostructured lipid carriers (NLCs) in a gel formulation to avoid side effects and to increase the absorption of topical TBF.
methodsTerbinafine-loaded nanostructured lipid carriers (TBF-NLCs) were developed and optimised using an ultrasonic probe technique, resulting in the formulation of TBF-NLCs as a 1% w/w carbopol gel after verifying the characteristics associated with NLCs. In vitro antifungal susceptibility test (AFST) was conducted on 85 prevalent fungal species associated with onychomycosis, as well as on strains isolated from trial participants, following the CLSI M38-A2 and M27-A3 guidelines. A total of 60 volunteers were enrolled in this clinical randomised, double-blind, placebo-controlled study, divided equally into three groups prescribed with TBF cream 1%, TBF-NLCs gel 1%, and a placebo.
resultsA monodisperse suspension of spherical nanoparticles was successfully produced, exhibiting a zeta potential of 18.4 ± 1.02 mV, a Z-average of 131.7 ± 5.32 nm, a PDI index of 0.280 ± 0.017, and an EE percentage of 83.51 ± 3.52, all without any cytotoxic effects. The severity index showed a reduction from 65% and 55% to 35% and 10% in the TBF cream 1% and TBF-NLCs groups, respectively. From a mycological perspective, no significant negative results were noted during the 6th and 8th weeks of TBF-NLC 1% gel application.
conclusionThe application of TBF-NLCs gel 1% demonstrated a quicker clinical recovery without adverse side effects compared to TBF cream, thus highlighting the effective nature of NLCs.
Indexed as
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What Socratic holds
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 Socratic graph.