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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04340128

Enrollment

Unknown

Registered

2020-04-09

Start date

2007-05-31

Completion date

2007-12-31

Last updated

2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Leishmaniasis

Keywords

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

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.

Interventions

DRUGMeglumine antimoniate

Intra-lesional injection once a week, 0.1/cm2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

9 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Complete healing of the lesion(s)	5 months

Secondary

Measure	Time frame
Partiall cure	5 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026