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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)

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ClinicalTrials.gov Identifier: NCT04340128
Recruitment Status : Completed
First Posted : April 9, 2020
Last Update Posted : April 9, 2020
Sponsor:
Collaborators:
Mashad University of Medical Sciences
Kerman University of Medical Sciences
Information provided by:
Tehran University of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniasis Drug: Meglumine antimoniate Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official 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)
Study Start Date : May 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Meglumine

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 Name: Glucantime

Experimental: 2
Intra-lesional injection twice a week, 0.1/cm2
Drug: Meglumine antimoniate
Intra-lesional injection twice a week, 0.1/cm2
Other Name: Glucantime




Primary Outcome Measures :
  1. Complete healing of the lesion(s) [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. Partiall cure [ Time Frame: 5 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340128


Locations
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Iran, Islamic Republic of
CRTSDL
Tehran, Iran, Islamic Republic of, 14166
Sponsors and Collaborators
Tehran University of Medical Sciences
Mashad University of Medical Sciences
Kerman University of Medical Sciences
Investigators
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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
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ClinicalTrials.gov Identifier: NCT04340128    
Other Study ID Numbers: j/423/2252
29463
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: February 2011
Keywords provided by Tehran University of Medical Sciences:
Anthroponotic Cutaneous Leishmaniasis
L. tropica
Meglumine antimoniate (Glucantime)
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Meglumine Antimoniate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents