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

April 6, 2020 updated by: Tehran University of Medical Sciences

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Intra-lesional injection of Glucantime once a week
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
Experimental: 2
Intra-lesional injection twice a week, 0.1/cm2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete healing of the lesion(s)
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Partiall cure
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Collaborators

Kerman University of Medical Sciences
Mashad University of Medical Sciences

Investigators

  • Study Director: Alireza Khatami, MD MSPH, Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences
  • Principal Investigator: Ali Khamesipour, PhD, Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences
  • Study Chair: Mahdieh Bahrami, MD, Kerman University of Medical Sciences
  • Study Chair: Mohammad Hossein Ghoorchi, MD, Mashhad University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • j/423/2252
  • 29463

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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