CompletedPhase 3

Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)

IranStarted 2007-05

Plain-language summary

Anthroponotic Cutaneous Leishmaniasis (ACL) is a parasitic disease caused by Leishmania tropica, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for leishmaniasis for last 80 years. Systemic antimonial injection is painful, toxic, not affordable and moreover is not always effective. Many different modalities are used to treat the disease with a limited success. Intra-lesional injections of antimonials are used for the treatment of patients with a few lesions but no data is available on the rate of efficacy. In this study the efficacy of intra-lesional injections of Glucantime weekly is compared with intra-lesional injections of Glucantime twice weekly.

Who can participate

Age range9 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Parasitologically proven cases of CL based on positive smear and/or culture * Otherwise healthy subjects on the basis of medical history. * Age 9-70 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 * History of allergy to Glucantime * Serious systemic illnesses (as judged by the physician) * Participation in any drug trials in the last 60 days * No indication for systemic treatment

What they're measuring

Complete healing of the lesion(s)

Timeframe: 5 months

Trial details

NCT IDNCT04340128

SponsorTehran University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-10