The Association of Miltefosine and Pentoxifylline to Treat Mucosal Leishmaniasis: A Clinical Trial in Brazil

Phase 3

Recruiting

• Conditions: eishmaniasis; Mucocutaneous leishmaniasis; C03.752.300.500; B55.2

• Registration Number: RBR-72dv9n
• Lead Sponsor: Pós Graduação de Ciências da Saúde - Universidade de Brasília

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion Criteria: Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis; ages between 18 and 80 years old; for patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm; fertile female patients should use at least two contraceptive methods (hormonal and barrier); agree to participate in the study and sign the informed consent term.

Exclusion Criteria

Exclusion Criteria: Use of any leishmanicidal drugs six months prior; clinical or laboratorial evidences of electrocardiographic disorders; renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS; hypersensitivity to meglucamine antimoniate; pregnancy or lactation; Fertile females that do not agree to use contraceptive methods; patients that do not agree to the informed consent term.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Access cure, failure or relapse. Cure being defined by complete healing of previous lesions until the 90th day after the begin of the treatment and non increase or decrease of indirect immunofluorescence title in the blood test; Failure being defined by presence of lesions previously documented that fail to heal until the 90th day after the begin of the treatment or lesions that increased or maintenance or increase in that indirect immunofluorescence title in the blood test; Relapse being defined as lesions that reappear on the scar of a previously healed lesion in the flow up time up to 180 days.

Secondary Outcome Measures

Name	Time	Method
Access the presence of side effect, verified by alterations on clinical or laboratorial exams higher than the reference value<br>;Access the need of treatment interruption due to adverse effects and toxicity verified by alterations on clinical or laboratorial exams higher than the reference value