Journal of the American Academy of Dermatology
Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis☆,☆☆,★,★★,♢
Section snippets
Study design
Baseline evaluation included recording information such as demographic data, medical history, duration of onychomycosis, and the presence or absence of chronic tinea pedis. A physical examination was conducted; clinical laboratory and mycologic sampling was carried out, ensuring that the eligibility criteria were met. Each eligible subject was randomly assigned to receive either the active treatment or matching vehicle for 48 weeks. Subjects reported to the clinic for evaluations by the
Study patients
In the first study (Study 312), a total of 223 individuals were randomized to treatment and were included in the ITT analysis (ciclopirox group: 112, vehicle group: 111). Of the patients randomized to treatment, 89 (79.5%) and 84 (75.7%) completed the study for the active and vehicle group, respectively. Similarly, 237 subjects were randomized to treatment in study II (Study 313) and were included in the ITT analysis (ciclopirox: 119 subjects, vehicle: 118). Of the patients randomized to
Non-US trials conducted to determine the efficacy and safety of ciclopirox nail lacquer
Thirteen trials that have been conducted outside of the United States using ciclopirox nail lacquer to treat onychomycosis of fingers and toes are summarized in Table IV.
Empty Cell Empty Cell Empty Cell Empty Cell Empty Cell Empty Cell Efficacy outcomes Study location Type of study Treatment regimen Toenails/fingernails Causative organisms Adverse events Mycologic cure Clinical cure Clinical response Finland Randomized double-blind Every 2nd day application × 3-6 months.
Discussion
Data from the pivotal US trials have demonstrated that ciclopirox nail lacquer is significantly more effective than placebo (vehicle) in the treatment of mild to moderate toe onychomycosis without lunula involvement, caused by T rubrum. These studies establish the efficacy of the nail lacquer for the treatment of onychomycosis in the great toe, which is usually difficult to treat because of disease extent, high rates of reinfection, and slow nail growth rates. In addition, the efficacy of
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Ciclopirox lacquer topical solution 8% package insert
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This article is part of a supplement sponsored by Aventis.
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Dr Baran and Dr Fleckman have been consultants for Aventis.
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Dr Gupta has been a consultant for Aventis, Janssen, Novartis, and Pfizer.
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Reprint requests: Aditya K. Gupta, MD, FRCP(C), 490 Wonderland Road South, Ste 6, London, Ontario Canada N6K 1L6.
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J Am Acad Dermatol 2000;43:S70-80.