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

Cutaneous Leishmaniasis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340128
• Other study ID #: j/423/2252
• Secondary ID: 29463
• Status: Completed
• Phase: Phase 3
• Start date: May 2007
• Est. completion date: December 2007

Study information

• Verified date: February 2011
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Drug:
• Meglumine antimoniate
Intra-lesional injection once a week, 0.1/cm2
• Meglumine antimoniate
Intra-lesional injection twice a week, 0.1/cm2

Locations

Country	Name	City	State
Iran, Islamic Republic of	CRTSDL	Tehran

Sponsors (3)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Kerman University of Medical Sciences, Mashad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete healing of the lesion(s)		5 months
Secondary	Partiall cure		5 months