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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cutaneous Leishmaniasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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1

Intra-lesional injection of Glucantime once a week

Group Type ACTIVE_COMPARATOR

Meglumine antimoniate

Intervention Type DRUG

Intra-lesional injection once a week, 0.1/cm2

2

Intra-lesional injection twice a week, 0.1/cm2

Group Type EXPERIMENTAL

Meglumine antimoniate

Intervention Type DRUG

Intra-lesional injection twice a week, 0.1/cm2

Interventions

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Meglumine antimoniate

Intra-lesional injection once a week, 0.1/cm2

Intervention Type DRUG

Meglumine antimoniate

Intra-lesional injection twice a week, 0.1/cm2

Intervention Type DRUG

Other Intervention Names

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Glucantime Glucantime

Eligibility Criteria

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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

Minimum Eligible Age

9 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No