Trial | NCT04340128  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
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 Started
May 31
2007
Primary Completion
Oct 31
2007
Study Completion
Dec 31
2007
Last Update
Apr 09
2020

Drug Meglumine antimoniate

Intra-lesional injection once a week, 0.1/cm2

  • Other names: Glucantime

Drug Meglumine antimoniate

Intra-lesional injection twice a week, 0.1/cm2

  • Other names: Glucantime

1 Active Comparator

Intra-lesional injection of Glucantime once a week

2 Experimental

Intra-lesional injection twice a week, 0.1/cm2

Criteria 

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
No Results Posted