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

NCT04340128 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-04-09

No results posted yet for this study

Summary

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.

Conditions

  • Cutaneous Leishmaniasis

Interventions

DRUG

Meglumine antimoniate

Intra-lesional injection once a week, 0.1/cm2

DRUG

Meglumine antimoniate

Intra-lesional injection twice a week, 0.1/cm2

Sponsors & Collaborators

  • Mashad University of Medical Sciences

    collaborator UNKNOWN

  • Kerman University of Medical Sciences

    collaborator OTHER

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Alireza Khatami, MD MSPH · Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences

  • Ali Khamesipour, PhD · Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences

  • Mahdieh Bahrami, MD · Kerman University of Medical Sciences

  • Mohammad Hossein Ghoorchi, MD · Mashhad University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2007-10-31
Completion
2007-12-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04340128 on ClinicalTrials.gov