Efficacy Trial on Oral Miltefosine in Comparison With Glucantime in the Treatment of ACL Caused by L. Tropica
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
Cutaneous leishmaniasis is a parasitic skin lesion caused by different species of Leishmania
and transmitted by the bite of infected sand flies. Leishmaniasis is exist in 88 countries,
pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a
standard treatment for this disease for last 80 years. Pentavalent antimonials are only
available as injectable, which is painful, toxic, not affordable and moreover is not always
effective even sometimes with several courses of treatment. Many different modalities are
used to treat the disease with little success. Miltefosine is drug and has recently been
shown to be effective in the treatment cutaneous leishmaniasis in Colombia. The molecular
mechanisms that contribute to this effectiveness are not clearly understood. Only a well
designed, randomized clinical trial can precisely evaluate the efficacy of any therapeutic
modalities in cutaneous leishmaniasis. In this study the efficacy of oral treatment of
miltefosine 2.5 mg per Kg body weight for 4 weeks will be compared with standard treatment of
intramuscular injections of 60 mg/kg/day glucantime for 2 weeks in ACL parasitologically
proven patients. At 8 weeks after the initiation of the treatment any patient in the group
who received miltefosine and has not responded to the treatment will be treated with the
standard intramuscular injections of 60 mg/kg/day glucantime for 2 weeks. The clinical trial
will be carried out according to the International approved GCP (Good Clinical Practice)
guide lines.