Int J Cancer. 2004 Aug 10;111(1):51-9.
Inhibition of human vascular endothelial cells proliferation by
terbinafine.
Ho PY, Liang YC, Ho YS, Chen CT, Lee WS.
Graduate Institute of Cellular and Molecular Biology, Taipei Medical
University, Taipei, Taiwan.
We have demonstrated previously that terbinafine (TB), an oral antifungal
agent used in the treatment of superficial mycosis, suppresses proliferation
of various cultured human cancer cells in vitro and in vivo by inhibiting
DNA synthesis and activating apoptosis. In our study, we further
demonstrated that TB at a range of concentrations (0-120 microM)
dose-dependently decreased cell number in cultured human umbilical
vascular endothelial cells (HUVEC). Terbinafine was not cytotoxic
at a concentration of 120 microM, indicating that it may have an
inhibitory effect on the cell proliferation in HUVEC. The TB-induced
inhibition of cell growth rate is reversible. [(3)H]thymidine incorporation
revealed that TB reduced the [(3)H]thymidine incorporation into
HUVEC during the S-phase of the cell-cycle. Western blot analysis
demonstrated that the protein levels of cyclin A, but not cyclins
B, D1, D3, E, CDK2 and CDK4, decreased after TB treatment. The TB-induced
cell-cycle arrest in HUVEC occurred when the cyclin-dependent kinase
2 (CDK2) activity was inhibited just as the protein level of p21
was increased and cyclin A was decreased. Pretreatment of HUVEC
with a p21 specific antisense oligonucleotide reversed the TB-induced
inhibition of [(3)H]thymidine incorporation. Taken together, these
results suggest an involvement of the p21-associated signaling pathway
in the TB-induced antiproliferation in HUVEC. Capillary-like tube
formation and chick embryo chorioallantoic membrane (CAM) assays
further demonstrated the anti-angiogenic effect of TB. These findings
demonstrate for the first time that TB can inhibit the angiogenesis.
Ann Hepatol.
2003 Jan-Mar;2(1):47-51.
Terbinafine hepatotoxicity. A case report and review of literature.
Zapata Garrido AJ, Romo AC, Padilla FB.
Hospital Christus Muguerza, Monterrey, Nuevo Leon, Mexico.
We report a 53-year old Mexican female who developed liver dysfunction
following a seven-day course of treatment with terbinafine for onychomycosis.
She presented with jaundice and abdominal pain. Her serum bilirubin
levels showed a peak value of 23.2 mg/dL seven weeks after discontinuing
the medication. Infectious causes (hepatitis viruses A, B and C)
were excluded. Imaging studies of the abdomen did not reveal any
abnormalities. Serum iron and ceruloplasmin levels were normal.
Autoantibodies were negative. A liver biopsy revealed necrosis and
mononuclear infiltration of the parenchyma, mainly along the sinusoids
and surrounding the portal spaces and biliary ducts. Eosinophil
infiltration of the portal spaces was also noted. Treatment with
ursodeoxycholic acid and ademethionine was started. Her liver tests
normalized in the sixth months after stopping terbinafine.
J Eur Acad
Dermatol Venereol. 2004 Mar;18(2):155-9.
Efficacy and tolerability of 8 weeks' treatment with terbinafine
in children with tinea capitis caused by Microsporum canis: a comparison
of three doses.
Devliotou-Panagiotidou D, Koussidou-Eremondi TH.
Department of Dermatology, Aristoteles University of Thessaloniki,
Mycological Laboratory of the State Hospital for Skin and Venereal
Diseases, Chalkidikis 51, GR-54644, Thessaloniki, Greece.
BACKGROUND: Tinea capitis caused by Microsporum canis is the most
common mycosis of the scalp in preschool and school-aged children
in Greece. OBJECTIVE: To compare the efficacy, safety and tolerability
of an 8-week course of oral terbinafine at different doses. METHODS:
Patients received oral terbinafine at doses ranging from 3.3 to
12.5 mg/kg/day for 8 weeks, as follows: group A, terbinafine 3.3
to 6.0 to 7.0 mg/kg/day (23 patients); group C, terbinafine >
7.0 to 12.5 mg/kg/day (37 patients). Fungal microscopy and cultures
were performed 4 weeks before the start of the treatment, at the
end of the treatment (week 8) and at a follow-up visit at week 16.
RESULTS: At week 8 mycological cure was achieved in one patient
(2.7%) in group A, in 21 patients (91.3%) in group B and in 34 patients
(97.1%) in group C. At week 16 mycological cure was achieved in
one patient (2.7%) in group A, in 22 patients (95.7%) in group B
and in 35 patients (100%) in group C. There was a statistically
significant difference (P < 0.0005) between dose level and efficacy
of terbinafine at the end of the treatment period and also at the
follow-up visit at week 16. Five patients (three in group A and
two in group C) discontinued treatment because of adverse events.
CONCLUSIONS: The administration of terbinafine at a dose of either
6-7 or 7-12.5 mg/kg/day for 8 weeks is safe and effective for the
treatment in children of tinea capitis caused by M. canis.
J Eur Acad
Dermatol Venereol. 2003 Nov;17(6):627-40.
The efficacy and safety of terbinafine in children.
Gupta AK, Adamiak A, Cooper EA.
Division of Dermatology, Department of Medicine, Sunnybrook and
Women's College Health Sciences Center (Sunnybrook site) and the
University of Toronto, Toronto, Canada.
Terbinafine is an allylamine antifungal agent that has been effective
and safe in the treatment of superficial and some deep mycotic infections
in adults. An increasing amount of data is available where terbinafine
has been used in the paediatric population to treat superficial
fungal infections, in particular tinea capitis. The data suggest
that terbinafine is effective and safe using treatment regimens
that involve short duration therapy, leading to an increased compliance
and providing a cost-effective means of treating paediatric superficial
fungal infections such as tinea capitis. Terbinafine has been approved
for the treatment of tinea capitis in many countries worldwide,
and provides good efficacy rates for Trichophyton tinea capitis
using shorter regimens than the gold standard griseofulvin. The
adverse events profile for children is similar to that in adults
with few adverse effects associated with its use. The evidence favours
the use of terbinafine in the treatment of superficial infections
in children.
J Cutan Med
Surg. 2003 Jul-Aug;7(4):306-11.
Terbinafine is more effective than itraconazole in treating toenail
onychomycosis: results from a meta-analysis of randomized controlled
trials.
Krob AH, Fleischer AB Jr, D
Westwood-Squibb Center for Dermatology Research, Wake Forest University
School of Medicine, Winston-Salem, North Carolina 27157-1071, USA.
BACKGROUND: Toenail onychomycosis is a challenge for clinicians
to treat, and this challenge is compounded by conflicting information
in the medical literature concerning the efficacy of the two principal
agents used in its treatment: terbinafine and itraconazole. OBJECTIVE:
The purpose of this meta-analysis is to compare the efficacy of
terbinafinewith that of itraconazole in the treatment of toenail
onychomycosis caused by dermatophytes. METHODS: A Medline search
was performed for all English language publications from 1966 to
June 1999 on the use of terbinafine and itraconazole in the treatment
of toenail onychomycosis. Included were randomized studies in which
subjects received no less than 3 months (or cycles) and no more
than 4 months (or cycles) of either terbinafine or itraconazole.
Data were abstracted and statistical analyses (random effects model,
fixed effects model, and Peto's method) were applied. RESULTS: Thirteen
studies were included from the original literature review of 1636
total referenced reports; four studies did not fulfill our inclusion
or exclusion criteria.The primary analysis of six studies directly
comparing terbinafine to itraconazole resulted in an odds ratio
ranging from 1.8 (95% CI = 1.8, 2.8) to 2.9 (1.9, 4.1). The secondary
analysis of three studies comparing either itraconazole or terbinafine
to placebo estimated an odds ratio of 1.1-1.7. The former shows
that terbinafine is 80%-190% more likely to result in mycologic
cure than is itraconazole; the latter demonstrates a 10%-70% greater
likelihood. The difference between the relative efficacies of terbinafine
and itraconazole was highly statistically significant (p < 0.0001).
CONCLUSION: Meta-analysis of the published worldwide literature
finds that terbinafine is significantly more effective than itraconazole
at achieving mycologic cure of toenail onychomycosis.
J Dermatolog
Treat. 2003 Dec;14(4):237-42.
An independent comparison of terbinafine and itraconazole in the
treatment of toenail onychomycosis.
Cohen AD, Medvesovsky E, Shalev R, Biton A, Chetov T, Naimer S,
Shai A, Vardy DA.
Dermatology Centre, Clalit Health Services (Southern District),
Beer-Sheva, Israel.
BACKGROUND: Previously, sponsored publications have shown that either
terbinafine or itraconazole (pulse regimen) are effective for patients
with toenail onychomycosis. However, independent comparative studies
are lacking. OBJECTIVES: To objectively compare treatment with terbinafine
and itraconazole in patients with toenail onychomycosis. METHODS:
The effectiveness of terbinafine (250 mg/day 3 months) versus itraconazole
pulse regimen (400 mg/day for the first week of each month, for
three cycles) was retrospectively evaluated in patients with toenail
onychomycosis using mycological tests and subjective outcome measures.
Statistical analyses were performed using one-way analyses of variance
(ANOVA) for continuous variables and Fisher exact tests for categorical
variables. RESULTS: Included in the study were 117 patients (74
patients treated by terbinafine and 43 patients treated with itraconazole).
Patients were examined at an average period of 20 months after the
end of therapy. Mycological cure was observed in 70.6% and 62.8%
of the patients who were treated by terbinafine or itraconazole,
respectively (not statistically significant). Mean visual analogue
scale assessment of treatment outcome was 79.9 mm (SD 24.7 mm) and
65.2 mm (SD 34.6 mm) for patients treated by terbinafine or itraconazole,
respectively (p=0.008). When the results were stratified according
to age and gender, it was observed that the advantage of terbinafine
versus itraconazole retained statistical significance only for patients
who were 55 years old and above, or females. CONCLUSIONS: Mycological
cure proportions were not statistically significant between patients
treated by terbinafine or itraconazole for toenail onychomycosis.
However, better subjective outcome measures indicated an advantage
for terbinafine over itraconazole, noticeable in females and patients
55 years old and above.
Am J Clin
Dermatol. 2003;4(1):39-65.
Terbinafine: a review of its use in onychomycosis in adults.
Darkes MJ, Scott LJ, Goa KL.
Adis International Inc., Langhorne, Pennsylvania 19047, USA.
Terbinafine, an orally and topically active antimycotic agent, inhibits
the biosynthesis of the principal sterol in fungi, ergosterol, at
the level of squalene epoxidase. Squalene epoxidase inhibition results
in ergosterol-depleted fungal cell membranes (fungistatic effect)
and the toxic accumulation of intracellular squalene (fungicidal
effect). Terbinafine has demonstrated excellent fungicidal activity
against the dermatophytes and variable activity against yeasts and
non-dermatophyte molds in vitro. Following oral administration,
terbinafine is rapidly absorbed and widely distributed to body tissues
including the poorly perfused nail matrix. Nail terbinafine concentrations
are detected within 1 week after starting therapy and persist for
at least 30 weeks after the completion of treatment. Randomized,
double-blind trials showed oral terbinafine 250 mg/day for 12 or
16 weeks was more efficacious than itraconazole, fluconazole and
griseofulvin in dermatophyte onychomycosis of the toenails. In particular,
at 72 weeks' follow-up, the multicenter, multinational, L.I.ON.
(lamisil vs Itraconazole in ONychomycosis) study found that mycologic
cure rates (76 vs 38% of patients after 12 weeks' treatment; 81
vs 49% of recipients after 16 weeks' therapy) and complete cure
rates were approximately twice as high after terbinafine treatment
than after itraconazole (3 or 4 cycles of 400 mg/day for 1 week
repeated every 4 weeks) in patients with toenail mycosis. Furthermore,
the L.I.ON. Icelandic Extension study demonstrated that terbinafine
was more clinically effective than intermittent itraconazole to
a statistically significant extent at 5-year follow-up. Terbinafine
produced a superior complete cure rate (35 vs 14%), mycologic cure
rate (46 vs 13%) and clinical cure rate (42 vs 18%) to that of itraconazole.
The mycologic and clinical relapse rates were 23% and 21% in the
terbinafine group, respectively, compared with 53% and 48% in the
itraconazole group. In comparative clinical trials, oral terbinafine
had a better tolerability profile than griseofulvin and a comparable
profile to that of itraconazole or fluconazole. Post marketing surveillance
confirmed terbinafine's good tolerability profile. Adverse events
were experienced by 10.5% of terbinafine recipients, with gastrointestinal
complaints being the most common. Unlike the azoles, terbinafine
has a low potential for drug-drug interactions. Most pharmacoeconomic
evaluations have shown that the greater clinical effectiveness of
oral terbinafine in dermatophyte onychomycosis translates into a
cost-effectiveness ratio superior to that of itraconazole, fluconazole
and griseofulvin. CONCLUSION: Oral terbinafine has demonstrated
greater effectiveness than itraconazole, fluconazole and griseofulvin
in randomized trials involving patients with onychomycosis caused
by dermatophytes. The drug is generally well tolerated and has a
low potential for drug interactions. Therefore, terbinafine is the
treatment of choice for dermatophyte onychomycosis.
Pharmacoeconomics.
2002;20(5):319-24.
Cost effectiveness of oral terbinafine (lamisil) compared with oral
fluconazole (Diflucan) in the treatment of patients with toenail
onychomycosis.
Salo H, Pekurinen M.
Health Services Research Ltd, Helsinki, Finland.
OBJECTIVE: To determine the cost effectiveness of terbinafine (lamisil)
tablets compared with fluconazole (Diflucan) capsules in the treatment
of patients with toenail onychomycosis. METHODS: Data from a randomised,
double-blind, double-dummy, multicentre study were used as the basis
for this study. Terbinafine 250 mg/day for 12 weeks (n = 48) was
compared with fluconazole 150mg once weekly for 12 weeks (n = 45)
or 24 weeks (n = 44) in patients with culture-confirmed toenail
onychomycosis caused by dermatophyte infection. At the end of the
study (week 60), complete clinical cure of the target toenail was
achieved in 67% of patients in the terbinafine group, compared with
21 and 32%, respectively, in the 12- and 24-week fluconazole groups.
We subsequently used these data to calculate the cost effectiveness
of the three treatment regimens, defining cost effectiveness as
the cost per complete clinical cure of the target toenail at week
60. RESULTS: The cost effectiveness of terbinafine for each complete
clinical cure was superior to that of either of the fluconazole
regimens. Costs per cure were Finnish markka (Fmk) 2824 ($US618)
for terbinafine, compared with Fmk3748 ($US820) and Fmk4922 ($US1077),
respectively, for the two fluconazole regimens. CONCLUSIONS: The
clinical study showed that terbinafine was significantly more effective
than fluconazole in the treatment of onychomycosis, achieving statistically
higher rates of mycological and clinical cure. We have now shown
that terbinafine is also more cost effective. These findings have
important implications for both medical and social policy.
Br J Dermatol.
2002 Feb;146(2):254-60.
Terbinafine (lamisil) treatment of toenail onychomycosis in patients
with insulin-dependent and non-insulin-dependent diabetes mellitus:
a multicentre trial.
Farkas B, Paul C, Dobozy A, Hunyadi J, Horvath A, Fekete G.
Department of Dermatology, Pecs University Medical Centre, Kodaly
u. 20, H-7624 Pecs, Hungary.
BACKGROUND: Diabetes mellitus (DM) affects an estimated 175 million
people world-wide. Approximately one-third of patients with DM have
toenail onychomycosis. OBJECTIVES: To determine the efficacy and
safety of terbinafine treatment of toenail onychomycosis in patients
with DM receiving insulin and/or oral antidiabetic agents. Special
interest was focused on potential drug interactions with oral hypoglycaemic
substances. METHODS: In a multicentre trial, patients suffering
from insulin-dependent DM (IDDM) or non- insulin-dependent DM (NIDDM)
with toenail onychomycosis were treated for 12 weeks with oral terbinafine
250 mg daily and followed up to 48 weeks. In addition to clinical,
mycological and laboratory investigations, blood glucose levels
were monitored. RESULTS: At the end of the trial (week 48), a mycological
cure rate of 73% was achieved. The rates of clinical cure and complete
cure (mycological cure plus clinical cure) were 57% and 48%, respectively.
There was no statistically significant difference between the NIDDM
and IDDM groups with respect to the cure rates (P > 0.05). No
hypoglycaemic episode was reported and none of the patients had
hypoglycaemia during the treatment phase. CONCLUSIONS: With excellent
cure rates and a good tolerability profile, terbinafine should continue
to be a drug of choice for the treatment of toenail onychomycosis
in the rising number of NIDDM patients receiving multiple medication.
Mycoses. 2001;44(7-8):300-6.
Once daily treatment with terbinafine 1% cream (lamisil) for one
week is effective in the treatment of tinea corporis and cruris.
A placebo-controlled study.
Budimulja U, Bramono K, Urip KS, Basuki S, Widodo G, Rapatz G, Paul
C.
Department of Dermato-Venereology, School of Medicine, University
of Indonesia, Jakarta.
Duration of therapy is an important factor in determining patients'
compliance in dermatomycosis. Terbinafine (lamisil) is an allylamine
antifungal agent. Its fungicidal properties against dermatophytes
should allow physicians to reduce treatment duration without affecting
the cure rate. This study was carried out to determine the efficacy
and tolerability of terbinafine 1% cream, applied once daily for
7 days, in adult patients with tinea corporis/cruris. In a multicentre,
randomized, double-blind, parallel-group study, patients with a
clinical diagnosis of tinea corporis/cruris confirmed by microscopy
and culture received treatment with either terbinafine 1% cream
(n = 57) or placebo cream (n = 60). The patients applied the cream
once daily for 7 days, and were then observed for a further 7 weeks.
The efficacy was assessed at the end of the study by comparing the
rates of mycological cure in the two treatment groups. Total clinical
signs and symptoms scores, clinical response, and overall treatment
efficacy were also measured and compared between the two groups.
A 7-day once-daily course of terbinafine was significantly more
effective than placebo in achieving and maintaining mycological
cure (84.2 versus 23.3%, P< 0.001). Terbinafine was also significantly
more effective than placebo in terms of clinical response, reduction
in signs and symptoms scores, and overall efficacy. The short treatment
regimen and the sustained high cure rate should contribute to making
terbinafine a valuable treatment option in tinea corporis/cruris.
Mycoses. 1999;42(9-10):555-8.
Oral terbinafine (lamisil) in the short-term treatment of fungal
infections of the skin: results of a post-marketing surveillance
study.
Binder M, Nell G.
Department of Dermatology, University of Vienna Medical School,
Austria.
Oral terbinafine (lamisil, Novartis Pharma AG, Basel, Switzerland)
is an effective therapy for fungal infections of the skin and nails.
A post-marketing surveillance study was undertaken to evaluate the
clinical efficacy and safety of oral terbinafine. A total of 454
patients with clinically and mycologically confirmed superficial
fungal infections of the skin were enrolled from 79 dermatology
clinics. Patients received oral terbinafine (250 mg day-1) for 2
weeks. Specific signs and symptoms were assessed by standard questionnaire
before, immediately after, and 4 weeks after treatment. Observed
improvements in patients after 2 weeks treatment were: erythema
81%, blistering 33%, exudation 50%, scaling 89%, pruritus 83%. After
4 weeks treatment, erythema was absent in 85% of patients, blistering
and exudation in 99.7%, scaling in 82%, and pruritus in 94%. Overall
clinical efficacy was assessed as good to excellent in 97% of patients.
Adverse effects--mainly gastrointestinal and minor skin rashes--were
reported in 5.3% of patients. The results of this study confirm
that oral terbinafine is safe and highly effective for the short-term
treatment of fungal skin infections.
Dermatology.
1997;194 Suppl 1:43-4.
The use of oral terbinafine (lamisil) in children.
Krafchik B, Pelletier J.
Department of Dermatology, Hospital for Sick Children, Toronto,
Canada.
In an ongoing study of lamisil in children, 21 patients have so
far been enrolled and preliminary data are reported in this paper.
Eighteen have tinea capitis and 1 has tinea corporis. So far, Trichophyton
tonsurans has been identified in 17 and Trichophyton violaceum in
2. lamisil has so far proved to be well tolerated, efficacious and
cost-effective in a 2-week course in those children with a Trichophyton
species. If Microsporum canis is isolated, a longer course is probably
indicated. lamisil has the distinct advantage of producing good
results in a short time period, making patient compliance less of
a problem.
Dermatology.
1997;194 Suppl 1:37-9.
Oral terbinafine (lamisil) in the treatment of fungal infections
of the skin and nails.
Roberts DT.
Department of Dermatology, Southern General Hospital, Glasgow, UK.
The efficacy and safety of antifungal drugs depend upon their mode
of action, the minimal inhibitory concentration (MIC) and its relationship
to the minimal fungicidal concentration (MFC), the spectrum of activity
and drug kinetics at the involved site. Terbinafine acts at the
fungal cell wall. Its MIC against dermatophytes is the lowest of
all currently available systemic antifungal agents. It is the only
one with an MIC:MFC ratio of 1:1 so that terbinafine should be effective
over very short treatment durations in dermatophyte infections of
the scalp, palms and soles, and nail, providing that drug penetration
is adequate, as it appears to be. Therapeutic levels persist for
a considerable period after the cessation of treatment, also favouring
short-duration therapy. Terbinafine is effective against all varieties
of dermatophyte. Terbinafine given over 4 weeks or less is effective
against Trichophyton of the scalp in children and adults. Its efficacy
in zoophilic ectrothrix infection is anecdotal, but it is likely
on theoretical grounds. Terbinafine is also effective against pityriasis
versicolor and vaginal candidosis, but only topically. As of March
1996, around 3,000,000 patients have been treated worldwide with
terbinafine, mostly for 12 weeks for toe-nail onychomycosis. Gastro-intestinal
disturbance and minor skin rashes are seen in 5 and 2% of patients,
respectively.
Dermatology.
1997;194 Suppl 1:27-31.
Effect of lamisil and azole antifungals in experimental nail infection.
Richardson MD.
Department of Dermatology, University of Glasgow, UK.
Onychomycosis is primarily caused by dermatophyte fungi but occasionally
by yeasts and non-dermatophytic moulds. The aim of this study was
to develop an in vitro model of nail invasion by dermatophytes,
yeasts and non-dermatophytic moulds, and to provide an alternative
system for studying the activity of different classes of antifungal
drugs against fungi associated with onychomycosis. In the absence
of extraneous nutrients, Trichophyton mentagrophytes was seen in
electron microscopy to degrade completely healthy nail plate. Candida
albicans germinated on nail fragments, but invasion of the nail
plate was not seen. The mould Fusarium formed long channels through
the matrix of the nail plate. Aspergillus versicolor appeared to
penetrate the outer and intermediate surface of the nail plate only.
Acremonium sp. and Scopulariopsis brevicaulis did not invade nail
in this model. Exposure of nail fragments to terbinafine (0.25 mg/l
for 3 h) inhibited invasion by T. mentagrophytes, C. albicans and
the non-dermatophytic moulds. Itraconazole (0.25 mg/l for 3 h) prevented
nail plate invasion by T. mentagrophytes, A. versicolor and Fusarium
but did not totally inhibit the surface growth of Acremonium or
S. brevicaulis. C. albicans grew in the presence of itraconazole.
The results indicate that terbinafine is readily absorbed by the
nail and that the drug is bio-available in nail keratin. A short
exposure of nail to low concentrations of terbinafine acted as a
barrier against fungal invasion. Itraconazole appeared to be effective
against Trichophyton and some non-dermatophytic moulds.
Br J Dermatol.
1995 May;132(5):683-9.
Overview of the use of terbinafine (lamisil) in children.
Jones TC.
Clinical Research Centre, Sandoz Pharma Ltd, Basle, Switzerland.
This review summarizes the efficacy and tolerability of terbinafine
(lamisil) in the treatment of dermatophytoses in children. In six
clinical studies, 152 children who received terbinafine were evaluable
for efficacy and 196 were evaluable for tolerability. In these studies,
terbinafine was used for between 1 and 28 weeks. The median treatment
was 4 weeks, the duration of treatment in the tinea capitis studies.
As a result of extensive experience in adults at doses of 10 mg/kg
and less, and the overall pharmacokinetic profile in children, including
the lower volume of distribution of terbinafine into lipophilic
tissue, the use of a dose of 125 mg/day for children weighing 20-40
kg, and 62.5 mg/day in children weighing less than 20 kg, has been
proposed. This dose was shown to be well tolerated and effective.
For children weighing > 40 kg, the adult dose of 250 mg is appropriate.
Terbinafine was shown to be very effective (93% cured), in the treatment
of children with tinea capitis, using a shorter treatment duration
(4 weeks) than that usually employed with presently available antifungal
drugs. It is also effective in children with various dermatophyte
infections of the skin, with a cure rate of more than 90%. Terbinafine
was shown to be well tolerated in children aged between 2 and 17
years. The recommended duration of treatment for tinea capitis is
4 weeks.
Br J Dermatol.
1994 Apr;130 Suppl 43:26-8.
Black piedra: the first case treated with terbinafine (lamisil).
Gip L.
Department of Dermatology, Boras Hospital, Sweden.
A 23-year-old Swedish Caucasian man presented with typical clinical
signs of black piedra of his scalp after his return from 4-months'
stay in India. There were black nodules around the hair shafts,
and the crushed nodules revealed numerous asci and ascospores on
microscopy. Piedraia hortae was isolated from the concretions. He
was treated with oral terbinafine 250 mg daily for 6 weeks. At the
end of treatment no nodules were visible, but 16 days later a few
'new' black concretions appeared. Microscopy of these nodules revealed
markedly degenerated fungal elements, and cultures were negative.
No further signs of the disease were seen 2 months after cessation
of therapy. In vitro susceptibility tests showed that Piedraia hortae
was sensitive to terbinafine. This case demonstrates that terbinafine
is effective in the treatment of black piedra.
Br J Dermatol.
1991 Sep;125(3):260-2.
Successful 2-week treatment with terbinafine (lamisil) for moccasin
tinea pedis and tinea manuum.
White JE, Perkins PJ, Evans EG.
Department of Dermatology, Royal South Hants Hospital, Southampton,
U.K.
A new orally active antifungal agent, terbinafine, was used in the
treatment of tinea pedis ('dry type' or moccasin type) and tinea
manuum. Fifty-three adults over the age of 16 years with fungal
infections of the feet and/or hands were treated with either oral
terbinafine, 250 mg, or placebo, once daily for 2 weeks. The diagnosis
of fungal infection was confirmed by examination of skin scrapings
by microscopy and culture. Of these, 28 patients were evaluable
for efficacy. At 8 weeks, 12 out of 14 (86%) patients who received
terbinafine were mycologically negative (microscopy and culture)
compared to one out of 14 (7%) patients on placebo (P less than
0.001, Fishers exact test, one-sided). At the end of the study 71%
of patients in the terbinafine group were judged to have received
effective therapy compared to 0% in the placebo group (P less than
0.001). Terbinafine was well tolerated, and more side-effects were
seen in the placebo group.
Br J
Dermatol. 1989 Dec;121(6):753-7.
Treatment of dermatophyte infection of the finger- and toe-nails
with terbinafine (SF 86-327, lamisil), an orally active fungicidal
agent.
Goodfield MJ, Rowell NR, Forster RA, Evans EG, Raven A.
Department of Dermatology, General Infirmary, Leeds, U.K.
We report on the use of a new orally active fungicidal agent, terbinafine
(SF 86-327, lamisil) in the treatment of patients with dermatophyte
onychomycosis. Twenty patients with toe-nail, and 10 with finger-nail
infection received 250 mg of terbinafine daily: finger-nail infections
were treated for 6 months and toe-nail infections for 12 months.
All 24 patients who completed the course of therapy achieved mycological
cure, as did two subjects who dropped out of the trial. All but
two patients had clinically normal nails at the end of the study
period. The mean time for mycological cure was 12.5 weeks for finger-nail
infection, and 24 weeks for toe-nail infections. The time for a
clinical cure with normal nails was 20.5 weeks for finger-nail infection,
and 44 weeks for toe-nail infection. An exacerbation of pre-existing
dyspepsia occurred in three of the six patients who did not complete
the trial but there were no other significant adverse reactions.