CASE REPORT AND UPDATES IN PARASITOLOGY

Leshcutan,  
a new available topical treatment for
cutaneous leishmaniasis


 

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Leishmaniasis designates a human disorder produced
by protozoan parasites of the genus Leishmania.
The cutaneous form of the disease (cutaneous leishmaniasis, CL),
is one of the most important causes of chronic ulcerative skin lesions.
The disease occurs clinically as either acute CL, chronic CL, recurrent CL and diffuse CL.
Photo 1a: Typical lesions of cutaneous leishmaniasis caused by L.major.

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Several species of Leishmania are involved, including L.major,
L.tropica and L. aethiopica on the Old World,
and several species of the L.braziliensis and L.mexicana in the New World.
The disease still presents a therapeutic problem in several parts of the world.
Both, parenterally (sodium stibogluconate, antimoy-N-methyl-glutamine,
pentasmidine and amphotericin-B) and orally
(rifampicin, dapson, ketoconazole, itraconazole and allopurinol)
administered drugs are available against the disease,
each with its own efficacy and attendant toxicity.
Photo 1b: Typical lesions of cutaneous leishmaniasis caused by L.major.

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In search of a new, innovative, simple, cheap and
effective ambulatory treatment for CL,
an ointment comprising of 15% paromomycin sulphate (PR)
and 12% methylbenzethonium chloride (MBCl)
in soft white paraffin (SWP) was developed (1).
This ointment was proven to be highly effective against a variety of leishmanial
strains both in human and in several animal models (1).
It is presently manufactured by Teva Pharmaceutical Industries
(P.O.Box 1142, Jerusalem 91010, Israel. Tel: 972-2-5892811; Fax: 972-2-5814345)
under the trade name "Leshcutan"
and is considered the first drug of choice for treating CL in Israel.
Photo 1c: Typical lesions of cutaneous leishmaniasis caused by L.major.

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Leshcutan was shown to have a wide range activity against various
Old and New World Leishmania strains from different endemic countries.
This treatment wich is generally given for 10 days, is cheap, easy to use,
with good compliance rate and minimal side effects.
Clinical studies with Leshcutan have so far been performed by us against strains of
L.major, L.tropica, L.aethiopica, L.mexicana and L.braziliensis (1,2).
More than 1.000 patients, male and females, with CL caused by L.major,
of various ages have been treated topically with Leshcutan.
This ointment applied twice daily to the CL lesion
for 10 days led to cures in 72% of patients (1,2).
After 10 days, treated lesions were free of parasites.
Photo 2a: Cutaneous leishmaniasis lesions caused by L.major,
before (left) and after treatment (right) with Leshcutan,
showing the healing of the lesion without scar formation.

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The clinical healing process was generally completed
within 10-30 days after termination of treatment.
Neither the type or duration of infection, the size and severity of the lesion,
nor secondary bacterial infection influences the response to treatment with P-ointment.
Also no antibiotic treatment was required prior to the Leshcutan treatment
in patients suffering from secondary bacterial infection,
and elimination of the parasites after this treatment was followed
by total elimination of the accompanying bacteria.
In humans treated with Leshcutan, routine laboratory examination including 
ESR, CBC, SMAC and urinalysis indicated no adverse side effects.
No penetration of the drug was demonstrated through normal uninjured skin
or through unopened nodules.
Photo 2b: Cutaneous leishmaniasis lesions caused
by L.tropica, before (left) and after treatment (right) with Leshcutan,
showing the healing of the lesion without scar formation.

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Generally, the clinical appearance of the lesion during and at the end
of treatment was worse than at the commencement.
Various degrees of inflammation, local pruritus, burning sensation
and local pain, depending on the size of the lesion and the host response,
were associated with this treatment.
In a few cases the treatment caused severe pain
associated with erythema and edema ^(2,3,6).
Several reports from different parts of the world on the effectiveness
of Leshcutan administered for different lenght of time have been published recently.
All these studies supported our previous results and again indicated
the high efficacy and the wide range of activity
of the P-ointment in the treatment of CL (3,4,5,6).
Photo 2c: Cutaneous leishmaniasis lesions caused by L.aethiopica,
before (left) and after treatment (right) with Leshcutan,
showing the healing of the lesion without scar formation.