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

NCT04340128 | Completed Phase 3

• 2 other identifiers: j/423/225229463
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Leishmaniasis

Keywords

Anthroponotic Cutaneous Leishmaniasis; L. tropica; Meglumine antimoniate (Glucantime)

Outcome Measures

Primary Outcomes (1)

• Complete healing of the lesion(s)

  5 months

Secondary Outcomes (1)

• Partiall cure

  5 months

Study Arms (2)

1

ACTIVE COMPARATOR

Intra-lesional injection of Glucantime once a week

Drug: Meglumine antimoniate

2

EXPERIMENTAL

Intra-lesional injection twice a week, 0.1/cm2

Drug: Meglumine antimoniate

Interventions

Meglumine antimoniate DRUG

Intra-lesional injection once a week, 0.1/cm2

Also known as: Glucantime

1

Eligibility Criteria

• Age: 9 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Mashad University of Medical Sciences: collaborator
• Kerman University of Medical Sciences: collaborator

Study Sites (1)

CRTSDL

Tehran, 14166, Iran

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Meglumine Antimoniate

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Hexosamines; Amino Sugars; Carbohydrates

Study Officials

• Alireza Khatami, MD MSPH

  Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences

  STUDY DIRECTOR

• Ali Khamesipour, PhD

  Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mahdieh Bahrami, MD

  Kerman University of Medical Sciences

  STUDY CHAIR

• Mohammad Hossein Ghoorchi, MD

  Mashhad University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: April 9, 2020
• Study Start: May 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 9, 2020

Record last verified: 2011-02

Locations

IR (1)