A novel two-step kit for topical treatment of tinea pedis –an open study A Shemer,† MH Grunwald,‡ B Davidovici,§ N Nathansohn,† B Amichai†,* †Department of Dermatology, Sheba Medical Center, Tel-Hashomer, ‡Soroka University Medical Center, Ben-Gurion University,Beer-Sheva, and §Dermatology Unit, Kaplan Medical Center, Rehovot, Israel *Correspondence: B Amichai. E-mail: [email protected] AbstractBackground Tinea pedis is a common skin disease affecting most of the population during their lifetime. Topical and systemic treatments give only temporary relief.
Objective To evaluate the efficacy and safety of a new topical treatment for moderate-to-severe tinea pedis.
Methods Fifty patients suffering from tinea pedis were treated in two stages: the active stage – single use of the novel topical solution for 45 min and novel cream twice weekly for 4 weeks; the preventive stage – cream application once weekly for 10 months.
Results Forty-five patients completed the active stage and achieved 76% cure rate. The medication was well tolerated; one patient dropped from the study because of very mild irritation. No other topical or systemic side effects were noted. Another five patients were lost to follow-up during the preventive stage. The total cure rate after Conclusions This novel treatment was found to be effective, well tolerated and safe in the treatment of moderate and severe tinea pedis during the active and the preventive stages.
Received: 27 October 2009; Accepted 18 December 2009 Tinea pedis is a common fungal infection in adults, affectingbetween 30% and 70% of the population.1,2 It often develops in persons with hyperhidrosis,3 particularly among men between 20 Fifty patients, males and females suffering from moderate-to- and 40 years of age.4 Elderly, diabetic and immunocompromised severe tinea pedis (moccasin type, interdigitalis type and vesiculob- patients are also at risk.4 The aetiologic pathogens most commonly ulous type) confirmed by mycological direct smear and culture associated with tinea pedis are Trichophyton rubrum, Trichophyton were enrolled in the study. Patients suffering from diabetic or mentagrophytes and Epidermophyton floccosum.1–5 stasis ulcers, peripheral vascular diseases or plantar keratoderma Fungal infection has a tendency to colonize the outer layer of including psoriasis were excluded. Pregnant and lactating women the skin, the stratum corneum. This layer serves as a reservoir of were also excluded. All patients stopped any topical or systemic food for fungi. Under conditions of moisture and the warm envi- antifungal treatment 4 months before entering the study. Patients ronment of the soles, the reaction between the fungus and the stra- known to have an allergy to at least one of the components of tum corneum produces a foul smelling odour. Itching, especially between the toes, is a very common complaint.3 Tinea pedis was confirmed by both KOH examination and Following effective treatment, patients return after several weeks mycological cultures of samples taken from the affected skin. Sam- to months with the same complaint; therefore, preventive treat- ples were divided into two parts; one was used for direct KOH ment is required. In this study, we evaluated the efficacy and safety examination and the second for fungal culture using Sabouraud’s of a new topical antifungal medication.
Dextrose Agar (Novamed, Jerusalem, Israel) that contains Journal compilation ª 2010 European Academy of Dermatology and Venereology chloramphenicol and penicillin to prevent bacterial contamina- patients (76%) had complete cure, two patients had marked tion. Identification of the fungus is done on the basis of micro- improvement, three patients had moderate improvement and two scopic morphological characteristics of the different fungi.
patients had mild improvement of their soles’ skin condition(Table 1).
Ten months later (after the preventive stage), the patients were The medication used in our study was a two-step kit: PedicureÔ re-examined and the findings were as follows: 35 (70%) patients Solution & PedicureÔ Cream (Pedicure Ltd., Tel-Aviv, Israel).
had no pathological finding – mycological analyses were negative The active ingredients in the solution were 0.5% climbazole (Fig. 1), 1 (2%) patient had slight dryness – mycological analysis and 14% glycolic acid 70%, and in the cream 0.5% climbazole and was negative for both direct smear and culture. Four (8%) patients had recurrence of the both clinical and mycological findings. Fivepatients were lost to follow-up (Table 2).
The study was conducted according the rules of the local HelsinkiCommittee and all patients provided written informed consentbefore enrolment.
Table 1 Results of treatment at the end of the active stage Classification of the severity of the disease was based on a 0–3 score of the parameters used by de Chauvin et al.6; 0 = none, 1 = mild, 2 = moderate, 3 = severe. The score was based on clinical signs and symptoms (erythema, desquamation, pruritus, pustules, vesiculation and incrustation) scored by the investigator Treatment was divided into two stages: active and preventive.
Active stage. A single treatment with the solution (Pedicuresolution); patients were instructed to put their feet in plastic bagsfilled with the solution for 45 min after which the feet were driedwith a towel. The cream (Pedicure cream) was applied twiceweekly for 4 weeks overnight for 6–8 h. The patients were askedto record any topical and ⁄ or systemic side effects that appearedduring treatment.
After 4 weeks of treatment (the active stage), the patients were re-examined clinically and mycologically (KOH examination andfungal culture) by the same physician; the improvement grade andside effects were evaluated.
Preventive stage. After the active stage, the cream wasapplied once weekly for 10 months. Patients were evaluated(clinically and mycologically) at the end of this preventive stage.
Each patient was assessed using the following score: total cure – both clinical and mycological cure; marked improvement – more Before treatment
After treatment
than 75% clinical cure; moderate improvement – 50–74% clinical Figure 1 Clinical picture showing results of treatment.
cure; mild improvement – 25–49% clinical cure; and failure – incases of 0–24% change. Worsening – if the clinical findings worsencompared with baseline.
Table 2 Results of treatment at the end of the preventive stage Of 50 patients, 24 men (mean age 42.5 years) and 26 women (mean age 47.1 years), suffering from moderate-to-severe tinea pedis, 45 patients completed the active stage, four patients did not return for follow-up and one patient experienced slight stinging after 20–30 min of treatment with the solution and discontinued the treatment. Of the 45 patients who completed the first stage, 38 Journal compilation ª 2010 European Academy of Dermatology and Venereology pedis with terbinafine and clotrimazole showed good efficacy of In tinea pedis, the fungal infection is localized in the stratum 75–80%, but the relapse rate in patients treated with terbinafine corneum, which serves as reservoir of food for fungi. Most of the was 15% and among clotrimazole patients, it was 19%. Savin and topical agents used in the treatment of tinea pedis usually have Jorizzo12 found that sertaconazole nitrate cream gave 70% myco- only fungicidic or fungistatic properties. The two-step kit used in logical cure after 4 weeks of treatment, but 2 weeks after cessation our study was composed of two types of active ingredients: of treatment only 47% remained mycological cure. This finding antifungal – climbazole, and keratolitic agents glycolic acid and stressed the need of prophylactic use of topical antifungal treat- urea, which were used to remove scales of stratum corneum.
ment. In our study, we showed similar cure rates at the end of the Climbazole (1-(4-chlorophenoxy)-1-(imidazole-1-yl) 3,3-dim- active stage of treatment, but prophylactic use of the medication ethylbutan-2-one) is an imidazole antifungal. Azole antifungals prevent the synthesis of ergosterol, the major sterol component offungal plasma membranes, by inhibiting the cytochrome P450 (CYP450)-dependent enzyme lanosterol 14-a-demethylase. The 1 Gupta AK, Tu LQ. Therapies for onychomycosis: a review. Dermatol subsequent depletion of ergosterol interferes with the structural 2 Baran R, Kaoukhov A. Topical antifungal drugs for the treatment of function of fungal membranes leading to leakage of cell contents.
onychomycosis: an overview of current strategies for monotherapy The net result is an inhibition of fungal growth and replication.7,8 and combination therapy. J Eur Acad Dermatol Venereol 2005; 19: Secondary effects, such as inhibition of the morphogenetic trans- 3 Masri-fridling GD. Dermatophytosis of the feet. Dermatol Clin 1996; formation of yeasts to the mycelial form, decreased fungal adher- ence and direct toxic effects on membrane phospholipids have 4 Zuber TJ, Baddam K. Superficial fungal infection of the skin. Where been reported in the literature.9 As azole antifungals, at therapeutic and how it appears help determine therapy. Postgrad Med 2001; 109: concentrations, bind more tightly to the fungal CYP450-depen- 5 Noble SL, Forbes RC, Stamm PL. Diagnosis and management of dent enzyme lanosterol 14-a-demethylase than to the mammalian common tinea infection. Am Fam Phys 1998; 58: 163–174.
enzyme,7 these compounds are considered safe for a variety of 6 de Chauvin MF, Viguie´-Vallanet C, Kienzler JL, Larnier C. Novel, single-dose, topical treatment of tinea pedis using terbinafine: results of The results of this study indicate that the above outlined treat- a dose-finding clinical trial. Mycoses 2008; 51: 1–6.
7 Sheehan DJ, Hitchcock CA, Sibley CM. Current and emerging azole ment was satisfactory in the treatment of fungal infection of the antifungal agents. Clin Microbiol Rev 1999; 12: 40–79.
soles during both active and preventive stages. The treatment was 8 Maertens JA. History of the development of azole derivatives. Clin well tolerated and no significant side effects were noted. Compli- Microbiol Infect 2004; 10(Suppl. 1): 1–10.
ance with treatment is enhanced by the fact that the treatment 9 Como JA, Dismukes WE. Oral azole drugs as systemic antifungal therapy. N Engl J Med 1994; 330: 263–272.
regimen does not require daily application of the drug. This novel 10 Albanese G, Di Di Cintio R, Giorgetti P, Galbiati G, Ciampini M.
treatment was based on combined antifungal compounds and Recurrent tinea pedis: a double blind study on the prophylactic use of keratolitic agents, which probably acted synergistically.
fenticonazole powder. Mycoses 1992; 35: 157–159.
Tinea pedis is extremely difficult to eradicate, as there are per- 11 Patel A, Brookman SD, Bullen MU et al. Topical treatment of interdigital tinea pedis: terbinafine compared with clotrimazole.
sistence conditions, mainly maceration, continuous use of topical Australas J Dermatol 1999; 40: 197–200.
antifungal medication is effective as a preventive therapy against 12 Savin R, Jorizzo J. The safety and efficacy of sertaconazole nitrate recurrences.10 Patel et al.11 reported that topical treatment of tinea cream 2% for tinea pedis. Cutis 2006; 78: 268–274.
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