mallefet_edit1.qxp 19/5/09 2:31 pm Page 27
Meta-analyses Comparing Topical Treatments for Tinea Pedis
Table 3 (cont.): Safety Data Reported in the Studies Included in the Meta-analyses
folliculitis and itching) were generally mild in severity and none of them led to
discontinuation of participation in the study.
Schachner, 1990
21
91 Naftifine 1% cream 2x/day 9/47 (19%) naftifine-treated patients reported AEs (mild to moderate pruritus, burning or
for 4 weeks erythema, and, in 2 patients, severe pruritus). 5/44 (11%) patients in the vehicle group
experienced AEs (mild to moderate pruritus, burning, or drying). No side effect was so
serious as to cause patients to withdraw from the study.
Bagatell, 1991
22
88 Naftifine 1% gel 2x/day 26 patients (8 naftifine, 18 vehicle) had treatment-related side effects (burning, stinging,
Study A for 4 weeks itching); none caused withdrawal from the study.
Bagatell, 1991
22
228 Naftifine 1% gel 2x/day 14 patients (6 naftifine, 8 vehicle) had treatment-related side effects (burning, erythema,
Study B for 4 weeks irritation, rash, stinging, pain, pruritic vesicles, ‘foul odour’ and pruritus); 2 (both in the
vehicle group) caused withdrawal from the study.
Coffey, 1986
23
93 Bifonazole 1% cream 1x/day Safety population (n=47 bifonazole; n=46 vehicle).
for 4 weeks No bifonazole-treated patients reported AEs. However, 2 vehicle-treated patients reported
AEs (severe dermatitis, which resolved when treatment was discontinued). No significant
laboratory abnormalities occurred in either group.
Izuno, 1986
24
81 Bifonazole 1% cream 1x/day During the study period, no bifonazole-treated patient reported AEs; 1 vehicle-treated
for 4 weeks patient developed moderate xerosis. No noteworthy laboratory changes occurred in
either group.
Bagatell, 1986
25
60 Bifonazole 1% solution 1x/day Safety population (n=30 bifonazole; n=30 vehicle).
for 4 weeks Burning sensation on application was reported in 2 bifonazole-treated patients and 1
vehicle-treated patient (3 episodes); none resulted in discontinuation of the treatment. No
other AEs were reported. There were no clinically significant laboratory test abnormalities.
Smith, 1986
26
139 Bifonazole 1% solution 1x/day The safety population contained the tinea pedis safety population (n=99: 49 bifonazole,
for 4 weeks 50 vehicle) and tinea versicolor safety population (n=40: 20 bifonazole, 20 vehicle).
3 bifonazole-treated and 2 vehicle-treated patients reported mild to moderate burning or
mild tingling sensation on application. The reactions were reversible; discontinuation of
therapy was unnecessary. No clinically significant changes were reported in laboratory
parameters in either group.
Ison, 1990
27
120 Econazole 1% cream 1x/day 12 AEs were reported in 12 patients (6 econazole, 6 vehicle); none was related to
for 4 weeks therapy or required discontinuation of therapy. There were no cutaneous AEs; the most
frequently reported were upper respiratory symptoms (5 patients: 2 econazole, 3 vehicle).
Other AEs were back pain (2 patients) and toothache (1 patient) in econazole treatment
group, and headache (2 patients) and pleurisy and swollen ankles (1 patient each) in
vehicle group. The overall incidence of side effects was not significantly different between
econazole and vehicle treatment groups.
Gentles, 1975
28
45 Miconazole cream 2% 1x/day Safety was not assessed in this study.
and miconazole powder 2%
each morning and after bathing
for 4 weeks
Ortiz, 1978
29
100 Miconazole cream (strength No adverse events were noted in either the active treatment or vehicle (control
not stated) 2x/day for 4 weeks vehicle) groups.
Smith, 1977
30
42 Clotrimazole 1% solution 2x/day Safety was not assessed in this study.
for 4 weeks
Spiekermann, 1976
31
1361 Clotrimazole 1% solution 2x/day The safety results in this paper do not distinguish between the patients (n=699) treated
Study A for 4 weeks with solution and cream, and nor do the results distinguish between the diagnosis (tinea
pedis, tinea cruris, tinea corporis, pityriasis versicolor and cutaneous candiadiasis).
Spiekermann, 1976
31
Clotrimazole 1% cream 2x/day However, only 19/699 (2.7%) patients treated with clotrimazole experienced drug-related
Study B for 4 weeks AEs (mostly irritation stinging, or burning), of whom 4 (0.6%) discontinued treatment;
incidence of possibly drug-related AEs in vehicle patients was similar (3%). No
hypersensitivity reactions were observed with use of clotrimazole; 2 cases of urticaria
were reported in patients treated with vehicle for solution (PEG 400).
Smith, 1988
32
64 Tioconazole 1% cream 2x/day 2 patients in the tioconazole group and 7 in the vehicle group complained of transient
for 6 weeks stinging or burning after application of the cream.
Ellis, 1989
33
266 Oxiconazole 1% cream 1x/day 8 patients in the oxiconazole groups experienced side effects, irritative in nature,
(n=87) or 2x/day (n=88) for 4 weeks which either disappeared with continued therapy or were tolerated with treatment.
Elewski, 1996
34
397 Oxiconazole 1% cream 2x/day for Adverse events (mostly burning and pruritus) reported in 25/397 (6.3%): 5.3% in the
4 weeks or oxiconazole 1% plus combination group, 7.5% in the monotherapy group and 6.0% in the vehicle group.
fluticasone 0.05% cream 2x/day for Withdrawals: 3 in the combination group, none in the monotherapy group and 1 in the
one week followed by oxiconazole vehicle group.
1% cream 2x/day for 3 weeks
Kligman, 1985
35
168 Ciclopiroxolamine 1% cream 2x/day One patient in each treatment group had worsening of clinical signs and symptoms,
for 4 weeks assessed by the investigator as probably related to treatment. No other adverse effects
were observed.
EUROPEAN DERMATOLOGY 27
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99