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

Tehran University of Medical Sciences

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Cutaneous Leishmaniasis

Interventions

Meglumine antimoniateDRUG

Intra-lesional injection once a week, 0.1/cm2

Meglumine antimoniateDRUG

Intra-lesional injection twice a week, 0.1/cm2

Eligibility

Sex: ALLMin age: 9 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

CRTSDL

Tehran, Iran

Outcomes

Primary Outcomes

Complete healing of the lesion(s)

Time frame: 5 months

Secondary Outcomes

Partiall cure

Time frame: 5 months

Data from ClinicalTrials.gov

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