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Efi6.5
Efinaconazol – Forschung
Überwiegend Mechanismus / Beobachtung
9 begutachtete Studien
Unsere Forschungsdatenbank hat nicht rechtzeitig geantwortet; diese Liste umfasst daher nur unsere kuratierten Studien. Wird automatisch aktualisiert.
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Efinaconazol sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus hochwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 2013–2026 mit einer typischen Studiengröße von 1,655 Teilnehmenden.
Basierend auf 9 Studien · 2 Meta-Analysen · 5 RCTs · 19,470 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Safety profile
Überwiegend Mechanismus / Beobachtung5 Studien
Hair & nails
Überwiegend Mechanismus / Beobachtung3 Studien
Aktives Forschungsgebiet
3 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 2020
201320192026
1Meta-AnalyseCited 42×n=12,501 · very large study2020
Einfach gesagt: Compared with vehicle, ciclopirox 8% lacquer may be more effective in achieving complete cure (risk ratio 9.29, 95% CI 1.72 to 50.14; low-quality evidence) and is probably more effective in achieving mycological cure (RR 3.15, 95% CI 1.93 to 5.12; moderate-quality evidence).
Foley K, et al. · Cochrane Database Syst Rev (2020)
56 studies, 12,501 participants. Only three were rated low risk of bias across all domains; the commonest high-risk domain was performance bias.
⚠️ The headline complete-cure risk ratio of 9.29 carries a confidence interval from 1.72 to 50.14 and is rated LOW quality. A relative effect that large on a small absolute base is not a precise estimate.
Mycological cure is the firmer finding: RR 3.15 (95% CI 1.93 to 5.12), moderate quality, from two studies and 460 participants.
Einfach gesagt: The primary end point, complete cure, was also significantly greater for efinaconazole (study 1: 17.8% vs 3.3%, study 2: 15.2% vs 5.5%, P < .001).
Elewski BE, et al. · J Am Acad Dermatol (2013)
Two identical multicentre randomised double-blind vehicle-controlled studies, 870 and 785 patients, randomised 3:1, once daily for 48 weeks with 4-week follow-up.
Primary endpoint was complete cure at week 52: 0% clinical involvement AND negative potassium hydroxide examination AND negative culture.
Mycological cure 55.2% and 53.4% against vehicle (P < .001), on the same trials whose complete-cure rates were 17.8% and 15.2%.
3Meta-AnalyseCited 17×2015
Einfach gesagt: Fluconazole, efinaconazole, ciclopirox, terbinafine nail solution, and amorolfine treatments were significantly superior to only placebo.
Gupta AK, et al. · J Am Podiatr Med Assoc (2015)
Network meta-analysis, needed because onychomycosis treatments are seldom compared head to head.
12-week continuous oral terbinafine 250 mg was superior to all treatments except itraconazole 400 mg pulse therapy.
⚠️ Ciclopirox beat placebo and nothing else. The abstract describes the topical therapies as equivalent to one another.
4ÜbersichtCited 1×n=1,655 · large study2014
Einfach gesagt: The combined results show a 56% mycologic cure rate compared with 17% for vehicle at week 52.
Gupta AK, Elewski BE, et al. · J Am Podiatr Med Assoc (2014)
Pooled report of the two pivotal trials across the United States, Canada and Japan, 1,655 patients.
Mycological cure 56% against 17% on vehicle at week 52.
⚠️ The abstract states a clinical treatment success figure twice and gives two different numbers, 43% and 47%. Neither is quoted here as the result because the abstract does not resolve which is which.
5RCTn=1,655 · large study2026
Einfach gesagt: At week 52, more efinaconazole- vs vehicle-treated participants achieved complete cure (White, 14.7% vs 2.0%; Asian, 27.5% vs 13.0%; Black, 12.9% vs 7.1%).
Elewski BE, et al. · J Drugs Dermatol (2026)
POST-HOC pooled analysis of the two phase 3 trials (NCT01007708, NCT01008033) by self-reported race: White 1,251, Asian 269, Black 98.
Complete cure: White 14.7% vs 2.0%, Asian 27.5% vs 13.0%, Black 12.9% vs 7.1%.
Mycological cure ranged 53.4% to 61.4% with efinaconazole against 10.7% to 30.4% with vehicle.
6RCTCited 2×n=218 · medium study2025
Einfach gesagt: At week 52, a significantly greater proportion of older adults (aged 65-71 years) achieved complete cure with efinaconazole than vehicle (13.6% vs. 3.6%; p < 0.05).
Gupta AK, et al. · Mycoses (2025)
POST-HOC pooled analysis of the same two phase 3 studies, restricted to participants aged 65 and over: 162 treated, 56 vehicle.
Complete cure 13.6% against 3.6% (p < 0.05); complete/almost complete cure 19.1% against 5.4% (p = 0.01); mycological cure 59.2% against 12.5% (p < 0.001).
Treatment-related adverse events were 6.0%, similar to the overall study population.
7RCTCited 6×n=1,655 · large study2018
Einfach gesagt: Baseline nail involvement did not appear to predict treatment outcomes.
Gupta AK, et al. · J Drugs Dermatol (2018)
POST-HOC pooled analysis of two identical multicentre randomised double-blind vehicle-controlled studies in 1,655 patients aged 18-70, asking whether baseline severity predicts cure.
⚠️ NULL RESULT, and it is the point of the paper: baseline nail involvement did not appear to predict treatment outcomes.
Of the 237 efinaconazole patients who were clear at week 52, 37% / 24% / 39% had mild / moderate / moderately severe disease at baseline, so cures were not concentrated in the mildest cases.
8Open-LabelCited 10×n=101 · medium study2021
Einfach gesagt: Mycological cure (MC) was 60.0% at M12, increasing to 74.2% at M24; effective cure (MC and ≤10% clinical involvement of the target toenail) was 17.8% at M12, rising to 19.4% at M24.
Gupta AK, et al. · Skin Therapy Lett (2021)
101 patients applying efinaconazole to all affected toenails once daily for 18 to 24 months, assessed at months 6, 12, 18 and 24.
⚠️ The key contrast: over a second year, mycological cure rose 14 points while effective cure rose 1.6. More fungus killed, barely more usable nails.
Application-site reactions in 8 patients (7.9%) were the only drug-related adverse events.
9RCTCited 14×n=30 · small study2019
Einfach gesagt: Both efinaconazole and combination with laser were efficacious treatment, but the combination therapy leads to quicker resolution with fewer rate of relapse.
Lim EH, et al. · J Cosmet Laser Ther (2019)
30 subjects randomised to efinaconazole alone or efinaconazole plus six Nd:YAG laser treatments every four weeks, over 48 weeks.
The combination reached mycological cure faster at the 48- and 52-week assessments.
⚠️ The stated primary endpoint was complete cure at week 52, and the abstract NEVER REPORTS IT. What it reports is a secondary mycological finding.