Efficacy and safety of a new single‐dose terbinafine 1% formulation in patients with tinea pedis (athlete's foot): a randomized, double‐blind, placebo‐controlled study
Abstract:Terbinafine 1% FFS, single dose application is an effective, safe and convenient treatment for tinea pedis. The relapse/re-infection rate 3 months after the end of single-dose therapy is similar to that previously demonstrated in a study using terbinafine 1% cream for 7 days.
“…When participants were re-evaluated at 3 months, 12.5% of those individuals considered mycologically cured at 6 weeks demonstrated positive cultures, comparable to the rates observed with other topical terbinafi ne formulations. 101 For more refractory (eg, hyperkeratotic) infections of the foot, effi cacy rates comparable to those described above can be observed with topical treatment; however, this may require protracted treatment durations (ie, several months). 55 In these cases, oral therapy has emerged as a reliable alternative.…”
Since terbinafi ne was introduced on the world market 17 years ago, it has become the leading antifungal for the treatment of superfi cial fungal infections, aided by unique pharmacologic and microbiologic profi les. This article reviews mode of action, antimycotic spectrum and disposition profi le of terbinafi ne. It examines the data, accumulated over 15 years, on the comparative effi cacy of terbinafi ne (vs griseofulvin, itraconazole, fl uconazole) in the management of the infections for which it is primarily indicated (eg, dermatophytoses) and provides a brief discussion on its use for the treatment of non-dermatophyte infections. Finally, the available data on the newest topical and systemic formulations are introduced.
“…When participants were re-evaluated at 3 months, 12.5% of those individuals considered mycologically cured at 6 weeks demonstrated positive cultures, comparable to the rates observed with other topical terbinafi ne formulations. 101 For more refractory (eg, hyperkeratotic) infections of the foot, effi cacy rates comparable to those described above can be observed with topical treatment; however, this may require protracted treatment durations (ie, several months). 55 In these cases, oral therapy has emerged as a reliable alternative.…”
Since terbinafi ne was introduced on the world market 17 years ago, it has become the leading antifungal for the treatment of superfi cial fungal infections, aided by unique pharmacologic and microbiologic profi les. This article reviews mode of action, antimycotic spectrum and disposition profi le of terbinafi ne. It examines the data, accumulated over 15 years, on the comparative effi cacy of terbinafi ne (vs griseofulvin, itraconazole, fl uconazole) in the management of the infections for which it is primarily indicated (eg, dermatophytoses) and provides a brief discussion on its use for the treatment of non-dermatophyte infections. Finally, the available data on the newest topical and systemic formulations are introduced.
“…In a second study, 190 patients with interdigital-type tinea pedis were treated with terbinafine 1% FFS and 83 with the vehicle. After 6 weeks, mycological cure was achieved in 72% of the patients receiving terbinafine 1% FFS compared to 21% of the patients who received the vehicle [34] . The relapse/reinfection rate of cured patients (12.5%) 3 months after the end of the single-dose therapy was similar to that previously seen when using terbinafine 1% cream for 7 days (9.3%) [26,34] .…”
Section: Efficacy Of Terbinafine In Comparison With Placebo and Azolementioning
confidence: 96%
“…After 6 weeks, mycological cure was achieved in 72% of the patients receiving terbinafine 1% FFS compared to 21% of the patients who received the vehicle [34] . The relapse/reinfection rate of cured patients (12.5%) 3 months after the end of the single-dose therapy was similar to that previously seen when using terbinafine 1% cream for 7 days (9.3%) [26,34] . Thus, in both studies terbinafine 1% FFS was significantly superior over the vehicle and the cure rates were close to those with 7-day treatment of terbinafine 1% cream applied once or twice daily [35] .…”
Section: Efficacy Of Terbinafine In Comparison With Placebo and Azolementioning
confidence: 96%
“…Similarly, single-application terbinafine 1% FFS has also shown a low incidence of side effects [34,36] . Thus, terbinafine is as effective and safe as azoles but is superior with regards to effectiveness based on its remarkably short treatment duration (i.e.…”
Section: Efficacy Of Terbinafine In Comparison With Placebo and Azolementioning
Terbinafine, a synthetic allylamine, exerts fungicidal activity against dermatophytes, the causative pathogens of tinea pedis. As proven in numerous clinical trials, tinea pedis can be effectively and safely treated by topical terbinafine. In fact, a 1-week application of terbinafine 1% cream eradicated fungal pathogens at least as effectively as 4-week treatment courses with topical azole derivative antifungals and showed lower relapse rates. A new innovative single-application formulation of terbinafine 1% in a film-forming solution produces a high concentration gradient on the skin surface and enables a prolonged (up to 13 days) exposure of the skin to terbinafine. High drug penetration into the skin results in an otherwise not obtained drug reservoir in the horny layer, the location of dermatophytes in tinea pedis. Although azole antimycotics can also effectively penetrate into the horny layer of the skin, short-term therapy might not be feasible due to its primarily fungistatic activity against dermatophytes. Thus, we conclude that the high efficacy of short-term treatment with terbinafine in patients with tinea pedis is possible due to its fungicidal activity coupled with a distinct reservoir formation in the upper layers of the epidermis.
“…Für die Indikation Tinea pedis dienten im Einzelnen Clotrimazol [14,15,16,17,18,19,20,21,22,23,24,25,26,27], Miconazol [28,29], Bifonazol [30,31], Butenafin [32] und Naftifin [33] …”
Section: Vergleichsstudien Terbinafin Vs Andere Antimykotikaunclassified
Superficial fungal infections are common and worldwide in distribution. Latest estimates suggest one- third of the population in Europe has a fungal infection of their feet, with dermatophyte infections of the skin of the feet (tinea pedis) most common. Tinea pedis interdigitalis is by far most common and can be effectively treated topically. Common agents include azoles, hydroxypyridones and allylamines, with morpholines used less frequently. While most antifungals have mainly fungistatic effects on dermatophytes, the causative agents of tinea pedis, terbinafine--an allylamine--is fungicidal. Due to this feature shorter treatment periods are possible using topical terbinafine. For effective treatment of uncomplicated tinea pedis interdigitalis, azole cream preparations are often used twice daily for four weeks whereas 1% terbinafine cream can be applied once a day for one week. Since 2006, 1% terbinafine is also available as a film-forming solution (FFS), which makes single-dose treatment possible. FFS may prove superior in daily practice with increased compliance and thus reduced recurrences.
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