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Cpx5.0
Ciclopirox – Forschung
Überwiegend Mechanismus / Beobachtung
9 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Ciclopirox 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 2000–2023 mit einer typischen Studiengröße von 460 Teilnehmenden.
Basierend auf 9 Studien · 2 Meta-Analysen · 5 RCTs · 13,919 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Hair & nails
Überwiegend Mechanismus / Beobachtung7 Studien
Safety profile
Zu wenige bewertete Studien2 Studien
Stetige Forschung
1 Studie in den letzten 5 Jahren · Neueste Meta-Analyse: 2020
200020112023
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: 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.
3RCTCited 4×n=381 · medium study2023
Einfach gesagt: No statistically significant differences were observed between patient groups in the proportion of subjects achieving a complete cure.
Sánchez-Regaña M, et al. · Mycoses (2023)
Phase III, multicentre, randomised, double-blind, 381 patients, 48 weeks of treatment with follow-up to week 52.
⚠️ The primary complete-cure endpoint was NULL across the new hydrolacquer, its vehicle and the active comparator.
On mycological cure it was NOT null: the hydrolacquer alone was significantly superior to vehicle for negativising dermatophyte culture (p = .039), at 32.0% against 23.2% vehicle and 27% reference.
Einfach gesagt: The combined results show a 34% mycologic cure rate, as compared with 10% for the placebo.
Gupta AK, et al. · J Am Podiatr Med Assoc (2000)
Reports the two pivotal US double-blind vehicle-controlled trials behind the FDA approval, alongside ten studies conducted worldwide.
Combined US mycological cure 34% against 10% on vehicle.
⚠️ The worldwide meta-analytic mean of 52.6% ± 4.2% is a separate figure from the 34% US result and should not be read as the same quantity.
5ÜbersichtCited 164×n=460 · medium study2000
Einfach gesagt: At the end of the 48-week treatment period, the mycologic cure rate in study I was 29% vs 11% in the ciclopirox and vehicle groups, respectively. Similarly, the mycologic cure rate for study II was 36% vs 9%.
Gupta AK, Joseph WS · J Am Acad Dermatol (2000)
Reviews two identically designed double-blind vehicle-controlled multicentre US trials, 223 and 237 patients randomised, alongside studies run outside the US.
Entry required clinical features plus positive microscopy AND positive dermatophyte culture, with 20% to 65% of the target nail involved.
Daily application for 48 weeks to all toenails and affected fingernails.
6RCTCited 69×n=467 · medium study2009
Einfach gesagt: The superiority of P-3051 vs. reference was nearly significant at week 48 (confirmed at week 52), and it was significant at week 60 (cure rate for P-3051 is 119% higher than reference; P < 0.05).
Baran R, et al. · J Eur Acad Dermatol Venereol (2009)
Multicentre randomised three-arm placebo-controlled evaluator-blinded trial, 467 patients, 48 weeks of treatment plus 12 weeks of follow-up.
P-3051 met its objective: superior to placebo and non-inferior to the marketed 8% lacquer on complete cure at week 48.
⚠️ The superiority claim rests on week 60, twelve weeks AFTER treatment stopped, having been only 'nearly significant' at the week-48 endpoint.
7RCTCited 35×n=40 · small study2013
Einfach gesagt: Mycologic cure was 70% in the treated group and 20% in the vehicle arm (p = 0.03) at week 12. At end of the study (week 32), 77% of treated patients achieved mycologic cure and 71% effective treatment, compared with 22% of the control.
Friedlander SF, et al. · Pediatr Dermatol (2013)
Prospective randomised double-blind vehicle-controlled trial in 40 children aged 2 to 16 with non-matrix onychomycosis, randomised 1:3.
Mycological cure 70% against 20% at week 12 (p = 0.03), and 77% against 22% at week 32.
The protocol included weekly lacquer removal and mechanical trimming, which is more than most people do at home.
8RCTCited 11×2017
Einfach gesagt: More subjects adhered to amorolfine (85%) than to ciclopirox (60%) (P = .025).
Iorizzo M, et al. · Mycoses (2017)
Two studies. Only Study A bears on ciclopirox: each subject received amorolfine on one foot and ciclopirox on the other for 12 weeks.
Adherence in Study A was 85% for once-weekly amorolfine against 60% for once-daily ciclopirox (P = .025).
In Study A satisfaction was 95% against 100% and preference 50% against 45%, so the adherence gap is about the regimen rather than dislike of the drug.
9RCTCited 16×n=70 · small study2005
Einfach gesagt: Using an intent to treat analysis, there was no significant difference in proportion of persons ulcerating in the AFL versus the NAFL groups (5.9% versus 5.6% P = 0.9).
Armstrong DG, et al. · Int Wound J (2005)
70 people at high risk of diabetic foot ulceration, randomised to daily self-inspection with or without ciclopirox 8%, followed for 12 months or until ulceration.
⚠️ NO reduction in ulceration. This is included because the hypothesis is attractive and the answer was negative.
Significantly fewer patients had clinically diagnosed hyperkeratosis or tinea pedis at study end, 52.9% against 77.8% (P = 0.03).