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

Phase 3

Completed

• Conditions: Cutaneous Leishmaniasis
• Interventions: Drug: Meglumine antimoniate

• Registration Number: NCT04340128
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2007-10
• Study Completion: 2007-12
• Status Verified: 2011-02
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2020-04-06
• Last Update Submitted: 2020-04-06
• Study First Posted: 2020-04-09
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Meglumine antimoniate	Intra-lesional injection twice a week, 0.1/cm2
1	Meglumine antimoniate	Intra-lesional injection of Glucantime once a week

Primary Outcome Measures

Name	Time	Method
Complete healing of the lesion(s)	5 months

Secondary Outcome Measures

Name	Time	Method
Partiall cure	5 months

Trial Locations

Locations (1)

CRTSDL; 🇮🇷 Tehran, Iran, Islamic Republic of