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Completed

NCT Number: NCT04340128

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

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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Key information

Conditions

Cutaneous Leishmaniasis Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Cutaneous Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

9 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CRTSDL

Tehran, 14166, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meglumine antimoniate

Drug

Intra-lesional injection once a week, 0.1/cm2

Other names: Glucantime

Primary outcomes

  1. Complete healing of the lesion(s)

    Time frame: 5 months

Secondary outcomes

  1. Partiall cure

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • Kerman University of Medical Sciences
  • Mashhad University of Medical Sciences

Registry information

Official study title

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)

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 9, 2020
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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