Study to evaluate the efficacy and safety of treatment of Cutaneous Leishmaniasis with Meglumine Antimonate applied directly to the lesion or Intramuscularly / Intravenously in several states of Brazil

Phase 3

Recruiting

• Conditions: American tegumentary leishmaniasis; B55.1

• Registration Number: RBR-6mk5n4
• Lead Sponsor: Instituto Nacional de Infectologia Evandro Chagas (INI) -Fiocruz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-08
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria
Patients who are able to sign the informed consent and willing to participate in the study as subjects attending the follow-up visits as foreseen by the study schedule;
Patients who present up to a maximum of three lesions with or without ulceration;
Patients with confirmed parasitic infection by Leishmania by scraping or imprint or histopathological examination or culture or immunohistochemistry or by polymerase chain reaction;
Patients who present lesions with a maximum of 5 cm in diameter for a single lesion or up to 3 cm for two lesions or up to 2 cm in the case of three lesions;

Exclusion Criteria

Women of childbearing age who do not use contraceptive methods or do so improperly;
Pregnant Women;
Children under the age of 13;
Patients with lesions in the cephalic segment;
Patients who have had previous treatment with MA;
Patients with disseminated or diffuse or recidiva cutis leishmaniasis;
Patients with of any form of leishmaniasis with mucous membrane involvement;
Patients with concomitant use of any medication with recognized toxic interactions with Sb5+ which cannot be substituted over the study period;
Patients with comorbid conditions such as heart or kidney or liver diseases.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of intralesional therapy with meglumine antimoniate for localized cutaneous leishmaniasis is expected to be no less than 20% as described with therapy systemic. The outcome will be evaluated within 180 days. Cure will be measured by the clinical evaluation of healed leishmaniasis lesions (complete epithelialisation and total involution of the infiltration interpreted as definitive healing).

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of adverse events 20% lower in the group treated with intralesional infiltration. The extent of adverse events will be by the number of adverse events reported in the adverse event records by the physician on days 15, 20 and 45 of the start of treatment.