Status:
COMPLETED
Efficacy Trial on Oral Miltefosine in Comparison With Glucantime in the Treatment of ACL Caused by L. Tropica
Lead Sponsor:
Tehran University of Medical Sciences
Collaborating Sponsors:
World Health Organization
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
12-60 years
Phase:
PHASE3
Brief 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 ant...
Detailed Description
Leishmaniasis caused by at least 20 different species of Leishmania and transmitted by the bite of infected sand flies. Leishmaniasis is endemic in 88 countries, mostly developing ones. Leishmaniasis ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00351520
Start Date
May 1 2006
End Date
June 1 2007
Last Update
September 20 2011
Active Locations (1)
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1
Ali Khamesipour
Bam, Kerman, Iran