Back to resultsEfficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)
Primary Purpose
Cutaneous Leishmaniasis
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Meglumine antimoniate
Meglumine antimoniate
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Leishmaniasis focused on measuring Anthroponotic Cutaneous Leishmaniasis, L. tropica, Meglumine antimoniate (Glucantime)
Eligibility 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
Sites / Locations
- CRTSDL
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Intra-lesional injection of Glucantime once a week
Intra-lesional injection twice a week, 0.1/cm2
Outcomes
Primary Outcome Measures
Complete healing of the lesion(s)
Secondary Outcome Measures
Partiall cure
Full Information
NCT ID
NCT04340128
First Posted
February 16, 2011
Last Updated
April 6, 2020
Sponsor
Tehran University of Medical Sciences
Collaborators
Mashad University of Medical Sciences, Kerman University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04340128
Brief Title
Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tehran University of Medical Sciences
Collaborators
Mashad University of Medical Sciences, Kerman University of Medical Sciences
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Leishmaniasis
Keywords
Anthroponotic Cutaneous Leishmaniasis, L. tropica, Meglumine antimoniate (Glucantime)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Intra-lesional injection of Glucantime once a week
Arm Title
2
Arm Type
Experimental
Arm Description
Intra-lesional injection twice a week, 0.1/cm2
Intervention Type
Drug
Intervention Name(s)
Meglumine antimoniate
Other Intervention Name(s)
Glucantime
Intervention Description
Intra-lesional injection once a week, 0.1/cm2
Intervention Type
Drug
Intervention Name(s)
Meglumine antimoniate
Other Intervention Name(s)
Glucantime
Intervention Description
Intra-lesional injection twice a week, 0.1/cm2
Primary Outcome Measure Information:
Title
Complete healing of the lesion(s)
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Partiall cure
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Khatami, MD MSPH
Organizational Affiliation
Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ali Khamesipour, PhD
Organizational Affiliation
Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahdieh Bahrami, MD
Organizational Affiliation
Kerman University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohammad Hossein Ghoorchi, MD
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
CRTSDL
City
Tehran
ZIP/Postal Code
14166
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
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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