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: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Collaborator: World Health Organization
• Treatments: Meglumine antimoniate; Miltefosine

Criteria

Inclusion Criteria:

• Parasitologically proven cases of CL based on positive smear and/or culture

• Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician)

• Age 12-60 years

• Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years).

Exclusion Criteria:

• Pregnant or lactating women

• Duration of lesion more than 6 months

• Number of lesions more than 4

• Ulcer size greater than 4 cm in their largest diameter

• History of full course of standard treatment (antimonials)

• History of allergy to Glucantime

• Serious systemic illnesses (as judged by the physician)

• Participation in any drug trials in the last 60 days