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

Status and phase: Completed; Phase 3

Conditions: Cutaneous Leishmaniasis

Treatments: Drug: Meglumine antimoniate

Study type: Interventional

Funder types: Other

Identifiers

NCT04340128

j/423/2252

29463

Details and patient eligibility

About

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.

Sex: All

Ages: 9 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

1

Active Comparator group

Description:

Intra-lesional injection of Glucantime once a week

Treatment:

Drug: Meglumine antimoniate

Drug: Meglumine antimoniate

2

Experimental group

Description:

Intra-lesional injection twice a week, 0.1/cm2

Treatment:

Drug: Meglumine antimoniate

Drug: Meglumine antimoniate