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Tinea Pedis
Table 3: Safety Data Reported in the Studies Included in the Meta-analyses
First Author N Active Treatment Safety Results
Ortonne, 2006
2
324 Terbinafine FFS 1%, 32 patients reported a total of 35 adverse events (AEs): 9% of terbinafine treated and
single application 11% of vehicle-treated patients reported 1 or more AEs. 5 patients (3 terbinafine, 2 vehicle)
reported an event suspected as related to study treatment, including mild burning (1
patient in each group), moderate peripheral oedema (1 patient in vehicle group) and mild
pain and moderate aggravated pruritus (each reported by 1 patient in terbinafine group).
No AEs were considered to be severe. At the end of the study, the safety and local
tolerability of terbinafine was rated as ‘good’ or ‘very good’ by 88% of investigators and
patients, respectively.
Feuilhade 466 Terbinafine FFS 1%, 5 or 9 patients (1, 3, 2 and 3 patients, respectively, randomised to terbinafine 1, 5 or
de Chauvin, 2008
3
10%, single application 10% or vehicle) experienced 12 AEs suspected of being related to study treatment;
8 occurred on the feet and comprised burning, dryness, eczema, irritation or pruritus
either at the application site or on the feet. Among patients randomised to terbinafine 1%,
there was only one AE suspected to be related to study treatment (mild pruritus). There
were no serious AEs among patients treated with terbinafine. Between 93 and 98% of
patients rated the tolerability of terbinafine as ‘good’ or ‘very good’ at the end of the trial.
Evans, 1991
10
86 Terbinafine 1% cream 1x/day There were 3 adverse events (2 terbinafine, 1 vehicle). 1 (erythematous rash on the
for 2 weeks hands and arms in a terbinafine-treated patient) was considered related to treatment.
Berman, 1992
11
165 Terbinafine 1% cream 2x/day Safety experience was not reported in this publication.
for 1 week
Korting, 2001
12
100 Terbinafine 1% cream 1x/day Terbinafine was well tolerated: 6 AEs were recorded (4 terbinafine, 2 vehicle). None were
for 1 week considered to be related to treatment. 3 AEs affected the skin (epidermal cyst,
terbinafine group; hyperhydrosis and herpes zoster, vehicle group).
Sigurgiersson, 1997
13
170 Terbinafine 1% solution 1x/day Safety was assessed, but no results are given in this abstract.
for 1 week
Lebwohl, 2001
14
153 Terbinafine 1% solution 2x/day Approximately 15% terbinafine (16/105 patients) and 10% vehicle group (5/48 patients)
for 1 week (interdigital experienced at least 1 AE. Most were mild and judged to be unrelated to drug. Skin or
tinea pedis) application-site reactions were reported in 7.6% (terbinafine) and 6.1% (vehicle). There
were no deaths, serious or severe AEs or discontinuations resulting from AEs. At the end
of the study, terbinafine tolerability was rated ‘good’ or ‘very good’ by 97% of patients
and investigators.
Hollmen, 2002
15
101 Terbinafine 1% gel 1x/day Terbinafine and vehicle were well tolerated. AEs were limited to mild to moderate
for 1 week application-site reactions and rashes.
Savin, 1997
16
393 Butenafine 1% cream 2x/day Safety population (n=197 butenafine; n=196 vehicle). AEs occurred in fewer than 1% of
for 1 week patients treated with butenafine and 2% of patients who applied vehicle. 6 AEs were
considered possibly, probably or definitely related to treatment: 1 (0.5%) in the butenafine
group (mild burning/stinging) and 5 in 4 patients (2%) in the vehicle group (3 experienced
burning or tingling at the application site, and 1 had elevated AST and ALT levels). No
patient withdrew from the study because of an AE. Nearly all laboratory test results were
within the normal range before and after treatment. No abnormal laboratory results were
judged to be clinically significant or at least possibly related to study medication in the
butenafine group.
Tschen, 1997
17
119 Butenafine 1% cream 1x/day Safety population (n=60 butenafine; n=59 vehicle). 1/60 butenafine-treated patients had
for 4 weeks an AE that was considered as possibly related to the study medication. This was a mild
burning sensation at the application site; the patient completed the treatment. Two other
butenafine-treated patients had abnormal laboratory test results during treatment, which
were considered unrelated to the study medication; in both cases the values returned to
normal by the end of the study. 4/59 vehicle-treated patients had AEs that were
considered as possibly related to the medication. 1 patient withdrew because of burning,
itching and stinging; 1 patient had severe itching during the first week of treatment that
abated by week 2; and 1 patient had a red streak (of 1 day’s duration) at the site that was
scraped for KOH and fungal culture specimens. The 4th patient had a high serum LDH
concentration at week 8 that returned to within the normal range 8 weeks after
treatment was stopped.
Reyes, 1998
18
150 Butenafine 1% cream 1x/day Butenafine safety population (n=77). 1 butenafine-treated patient had an AE,
for 4 weeks considered to be possibly related to study drug (an episode of moccasin-type tinea pedis
of the plantar surface). 1 butenafine-treated patient had a treatment-emergent clinically
abnormal laboratory test result: hyperbilirubinemia, attributable to patient’s personal and
family history.
Klaschka, 1984
19
60 Naftifine 1% gel 2x/day Mild to moderate burning feeling or dryness were reported by 11 patients with naftifine
for 4 weeks and by 15 with vehicle. Treatment was discontinued early by 1 patient in each group.
Dobson, 1989
20
183 Naftifine 1% cream 1x/day 2 naftifine and 5 vehicle-treated patients experienced reactions that may have been
for 4 weeks attributable to treatment. These reactions (soreness, burning, eczema, exacerbation of
26 EUROPEAN DERMATOLOGY
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