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Tinea Pedis
Table 3 (cont.): Safety Data Reported in the Studies Included in the Meta-analyses
Aly, 2003
36
374 Ciclopirox 0.77% gel 2x/day All treatment-emergent, treatment-related AEs were localised reactions. Burning sensation
for 4 weeks of the skin was the most commonly reported AE in both groups (14 ciclopirox, 13 vehicle);
many of these patients had fissures. 3 ciclopirox- and 1 vehicle-treated patients reported
pruritus. There were no discontinuations from treatment for safety reasons.
Gupta (2005)37 100 Ciclopirox 0.77% gel 2x/day There was no significant difference in the AE rate between treatments. AEs, probably or
for 4 weeks possibly due to treatment, were found in 65, 57.5 and 70% of twice-daily, once-daily
and vehicle patients, respectively. Most AEs were mild to moderate; the most common
was intermittent or single episodes of burning and/or itching at the application site.
No patient discontinued the study because of an AE.
N = number of patients in the safety population.
extended these findings by showing that a single application of
terbinafine FFS is non-inferior, at least from a descriptive standpoint,
Jean-Paul Ortonne is a Professor of Dermatology and Chairman of the Department of
Dermatology at the University of Nice-Sophia Antipolis. His major medical interests are
to multiple applications (typically one or two daily applications for
in the areas of melanin pigmentary disorders. He is a founding member and Past
four weeks) of all the other clinically used topical agents. In this President of the French Society for Dermatological Research. Dr Ortonne is the author
regard, a single application of terbinafine 1% FFS is non-inferior to
or co-author of more than 560 clinical or research papers, inluding Vitiligo and other
Hypomelanoses of Hair and Skin.
the azoles as a group when used for many weeks of treatment, and
even superior to some of them (clotrimazole, oxiconazole). A single
Martine Feuilhade de Chauvin works in the Mycology Department of Saint Louis
application of terbinafine 1% FFS is also non-inferior to other
Hospital APHP, University Paris VII. Since the 1980s she has been participating in phase
II and III clinical trials of dermatomycoses. She is a member of the French Society of
allylamines (butenafine, naftifine) and descriptively superior to
Dermatology and Venereology and the European Academy of Dermatology and
ciclopiroxolamine when used for many weeks.
Venereology (EADV).
Hans Christian Korting is Acting Executive Academic Director at the Department of
A treatment that is effective after a single application (and for which
Dermatology and Allergology of Ludwig-Maximilian-University. His scientific focus is on
compliance may be presumed to approach 100%) represents a
cutaneous microbiology, immunology and dermatopharmacology. He is the Editor in
significant advantage over the topical alternatives, which require
Chief of Mycoses and the author of 418 journal articles. Dr Korting completed a
doctorate in medicine at the Johannes-Gutenberg-University in 1977 and became a
repeated applications once or twice a day over a period of weeks, a
dermatologist and venereologist in 1983.
requirement often associated with poor compliance. ■
1. Korting HC, Kiencke P, Nelles S, Rychlik R, Comparable 13. Sigurgeirsson B, Foged E, Lassen E, Once daily, one week 1986;3(5):308–16.
efficacy and safety of various topical formulations of treatment with terbinafine 1% solution for interdigital 25. Bagatell FK, Elimination of dermatophytes causing tinea
terbinafine in tinea pedis irrespective of the treatment tinea pedis (Athlete’s foot), J Eur Acad Dermatol Venereol, pedis interdigitalis with once-daily application of
regimen, Am J Clin Dermatol, 2007;8(6):357–64. 1997;9(Suppl. 1):S195. bifonazole 1% solution, Adv Ther, 1986;3(5):265–71.
2. Ortonne JP, Korting HC, Viguié-Vallanet C, et al., Efficacy 14. Lebwohl M, Elewski B, Eisen D, Savin RC, Efficacy and 26. Smith EB, Tschen E, Treatment of interdigital tinea pedis
and safety of a new single-dose terbinafine 1% safety of terbinafine 1% solution in the treatment of and tinea (pityriasis) versicolor with bifonazole 1%
formulation in patients with tinea pedis (athlete’s foot): a interdigital tinea pedis and tinea corporis or tinea cruris, solution applied once daily, Adv Ther, 1986;3(5):250–56.
randomized, double-blind, placebo-controlled study, J Eur Cutis, 2001;67:261–6. 27. Ison AE, Lufrano L, Thorne EG, Once-daily application of
Acad Dermatol Venereol, 2006;20:1307–13. 15. Hollmen KA, Kinnunen T, Kiistala U, et al., Efficacy and econazole nitrate in the treatment of tinea pedis, Adv Ther,
3. Feuilhade de Chauvin M, Viguié-Vallanet C, Kienzler J-L, tolerability of terbinafine 1% emulsion gel in patients with 1990;7(3):119–23.
Larnieret C, Novel, single-dose, topical treatment of tinea tinea pedis, J Eur Acad Dermatol Venereol, 2002;16:81–94. 28. Gentles JC, Jones GR, Roberts DT, Efficacy of miconazole in
pedis using terbinafine: results of a dose-finding clinical 16. Savin R, De Villez RL, Elewski B, et al., One-week therapy the topical treatment of tinea pedis in sportsmen, Br J
trial, Mycoses, 2008;51(1):1–6. with twice-daily butenafine 1% cream versus vehicle in Dermatol, 1975;93:79–84.
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7. Whitehead AJ, A general parametric approach to the treatment of interdigital tinea pedis, Int J Dermatol, in tinea pedis, Adv Ther, 1988;5(6):313–18.
meta-analysis of randomized clinical trials, Statistics in 1998;37(6):450–53. 33. Ellis CN, Gammon WR, Goldfarb MT, et al., A
Medicine, 1991;10:1665–77. 19. Klaschka F, Gartmann H, Weidinger G, Antimykotikum placebo-controlled evaluation of once-daily versus
8. Whitehead A, Meta-analysis of controlled clinical trials, John naftifin. Placebo-kontrollierte Therapievergleich bei Tinea twice-daily oxiconazole nitrate (1%) cream in the
Wiley & Sons Ltd, 2002. pedum, Z Hautkr, 1984;59(18):1218–25. treatment of tinea pedis, Curr Ther Res, 1989;46(2):269–76.
9. CPMP/EMEA (2001), Points to consider on application with 20. Dobson RL, Binder R, Hickman JG, Once-daily naftifine 34. Elewski B, Jones T, Zaias N, Comparison of an antifungal
1. Meta-analyses; 2. One pivotal trial, 2008. Available at: cream 1% (Naftin) in the treatment of tinea pedis, Clin Trials agent used alone and an antifungal used with a topical
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11. Berman B, Ellis C, Leyden J, et al., Efficacy of a 1-week, 22. Bagatell FK, Bart BJ, Cole B, et al., Naftifine gel in the 36. Aly R, Fisher G, Katz HI, et al., Ciclopirox gel in the
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28 EUROPEAN DERMATOLOGY
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