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Tinea Pedis
Table 1: Randomised Double-blind Vehicle-controlled Studies Included in the Meta-analyses – Details and Results
First Author N Active Treatment Vehicle Mycological Cure Active
n/N (%±SE) n/N (%±SE)
Ortonne, 2006
2
273 Terbinafine FFS 1%, single application 17/83 20.5±4.4% 136/190 71.6±3.3%
Feuilhade de Chauvin, 2008
3
344 Terbinafine FFS 1, 5 or 10%, single application 12/48 25.0±6.3% 90/109 82.6±3.6%
Evans, 1991
10
86 Terbinafine 1% cream 1x/day for 2 weeks 9/20 45.0±11.1% 22/28 78.6±7.8%
Berman, 1992
11
165 Terbinafine 1% cream 2x/day for 1 week 18/79 22.8±4.7% 70/80 87.5±3.7%
Korting, 2001
12
100 Terbinafine 1% cream 1x/day for 1 week 13/35 37.1±8.2% 32/35 91.4±4.7%
Sigurgiersson, 1997
13
* 172 Terbinafine 1% solution 1x/day for 1 week 9/39 23.1±6.7% 60/71 84.5±4.3%
Lebwohl, 2001
14
153 Terbinafine 1% solution 2x/day for 1 week 4/28 14.3±6.6% 52/58 89.7±4.0%
Hollmen, 2002
15
101 Terbinafine 1% gel 1x/day for 1 week 7/31 22.6±7.5% 25/39 64.1±7.7%
Savin, 1997
16
271 Butenafine 1% cream 2x/day for 1 week 31/139 22.3±3.5% 98/132 74.2±3.8%
Tschen, 1997
17
80 Butenafine 1% cream 1x/day for 4 weeks 13/40 32.5±7.4% 35/40 87.5±5.2%
Reyes, 1998
18
150 Butenafine 1% cream 1x/day for 4 weeks 33/52 63.5±6.7% 48/53 90.6±4.0%
Klaschka, 1984
19
60 Naftifine 1% gel 2x/day for 4 weeks 0/30 0.0±2.3% 29/30 96.7±3.9%
Dobson, 1989
20
183 Naftifine 1% cream 1x/day for 4 weeks 16/88 18.2±4.1% 63/95 66.3±4.8%
Schachner, 1990
21
91 Naftifine 1% cream 2x/day for 4 weeks 13/44 29.5±6.9% 29/47 61.7±7.1%
Bagatell, 1991
22
Study A 88 Naftifine 1% gel 2x/day for 4 weeks 7/46 15.2±5.3% 24/42 57.1±7.6%
Bagatell, 1991
22
Study B 228 Naftifine 1% gel 2x/day for 4 weeks 19/111 17.1±3.6% 85/117 72.6±4.1%
Coffey, 1986
23
43 Bifonazole 1% cream 1x/day for 4 weeks 1/18 5.6±5.4% 9/25 36.0±9.6%
Izuno, 1986
24
38 Bifonazole 1% cream 1x/day for 4 weeks 6/18 33.3±11.1% 16/20 80.0±8.9%
Bagatell, 1986
25
47 Bifonazole 1% solution 1x/day for 4 weeks 8/21 38.1±10.6% 17/26 65.4±9.3%
Smith, 1986
26
54 Bifonazole 1% solution 1x/day for 4 weeks 6/31 19.4±7.1% 20/23 87.0±7.0%
Ison, 1990
27
120 Econazole 1% cream 1x/day for 4 weeks 15/57 26.3±5.8% 41/54 75.9±5.8%
Gentles, 1975
28
45 Miconazole cream 2% 1x/day and miconazole powder 6/25 24.0±8.5% 12/20 60.0±11.0%
2% each morning and after bathing for 4 weeks
Ortiz, 1978
29
100 Miconazole cream (strength not stated) 2x/day for 4 weeks 7/50 14.0±4.9% 46/50 92.0±3.8%
Smith, 1977
30
30 Clotrimazole 1% solution 2x/day for 4 weeks 7/15 46.7±12.9% 11/15 73.3±11.4%
Spiekermann A, 1976
31
267 Clotrimazole 1% solution 2x/day for 4 weeks 52/134 38.8±4.2% 89/133 66.9±4.1%
Spiekermann B, 1976
31
41 Clotrimazole 1% cream 2x/day for 4 weeks 6/24 25.0±8.8% 11/17 64.7±11.6%
Smith, 1988
32
64 Tioconazole 1% cream 2x/day for 6 weeks 3/30 10.0±5.5% 20/30 66.7±8.6%
Ellis, 1989
33
266 Oxiconazole 1% cream 1x/day (n=87) or 15/49 30.6±6.6% 85/114 74.6±4.1%
2x/day (n=88) for 4 weeks
Elewski, 1996
34
404 Oxiconazole 1% cream 2x/day for 4 weeks or 30/106 28.3±4.4% 64/104 61.5±4.8%
oxiconazole 1% plus fluticasone 0.05% cream 2x/day
for one week followed by oxiconazole 1% cream
2x/day for 3 weeks
Kligman, 1985
35
168 Ciclopiroxolamine 1% cream 2x/day for 4 weeks 36/83 43.4±5.4% 49/85 57.6±5.4%
Aly, 2003
36
374 Ciclopirox 0.77% gel 2x/day for 4 weeks 25/157 15.9±2.9% 136/160 85.0±2.8%
Gupta, 2005
37
100 Ciclopirox 0.77% gel 2x/day for 4 weeks 9/20 45.0±11.1% 65/80 81.3±4.4%
N = number of patients randomised. *Also internal statistical report, Foged, Novartis Consumer Health SA, 1996.
using meta-analytical methods on all available good-quality • The trial had to be randomised, double-blind and comparative
randomised vehicle-controlled clinical trials. versus vehicle.
• The trial had to evaluate the efficacy and safety of topical
Methods treatments in patients with interdigital tinea pedis. Studies
Search Strategy for Identification of Studies based on moccasin-type tinea pedis were excluded from the
An exhaustive literature search for published trials in the treatment meta-analyses.
of tinea pedis was carried out. Publications reporting the results of • Mycological cure (based on both negative microscopy and
treatments for tinea pedis were sought without any language negative culture) had to be an available outcome in the trial. If
restriction. External databases searched included Medline (from 1950 microscopy and culture were not reported together, they had
to 2008) and Excerpta Medica (from 1980 to 2008). Publications of to have at least been assessed and reported, even if separately.
clinical studies and reviews were included. The search strategy used • At least 30 patients had to be evaluable in the trial. Although this
the key words terbinafine/tinea-pedis/topical-drug-administration or criterion is somewhat subjective, we considered that estimated
tinea-pedis/topical-drug-administration/clinical trials. Unpublished cure rates in trials with fewer than 30 patients could be unreliable.
trials sponsored by Novartis assessing the efficacy of terbinafine in the
treatment of tinea pedis were also screened using a similar search Description of Studies
strategy on three internal databases (National Institute for Discovery Seventy-eight publications were identified by the literature search.
Science [NIDS], E-NOVA and OTC-AskMe). Studies were assessed and selected for inclusion using the criteria
described above. Thirty-two studies satisfied these criteria and were
Selection Criteria considered in the meta-analyses presented here. The studies that
Trials included in the meta-analyses had to meet the following criteria: were included in the meta-analyses are summarised in Table 1.Of
20 EUROPEAN DERMATOLOGY
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